Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia
NCT ID: NCT00550992
Last Updated: 2019-07-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
445 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-01-31
Brief Summary
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RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia.
PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.
PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.
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Detailed Description
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OBJECTIVES:
Primary
* To compare an early intensification regimen comprising two "acute myeloid leukemia" induction therapy blocks with a standard protocol IB regimen administered directly after induction therapy in medium-risk (MR) and high-risk (HR) patients with newly diagnosed acute lymphoblastic or biphenotypic leukemia.
Secondary
* To compare through a randomized study the role of these regimens in treating these patients.
* To compare the overall outcome of the Interfant-06 study with outcomes in the historical control series, especially in the Interfant-99 study.
* To compare the outcomes of low-risk, MR, or HR patients in this study with those of patients in the historical control series Interfant-99 study.
* To study which factors have independent prognostic value in patients treated with these regimens.
* To assess the role of stem cell transplantation in HR patients.
OUTLINE: This is a multicenter study.
* Induction therapy:
* Prednisone phase: Patients receive prednisone orally or IV three times daily on days 1-7 and methotrexate (MTX) and prednisolone (PRDL) intrathecally (IT) on day 1. Patients then proceed to remission induction therapy.
* Remission induction phase: Patients receive dexamethasone (DEXA) IV or orally three times daily on days 8-28 followed by a taper to 0 over 1 week; vincristine (VCR) IV on days 8, 15, 22, and 29; cytarabine (ARA-C) IV over 30 minutes on days 8-21; daunorubicin hydrochloride (DNR) IV over 1 hour on days 8 and 9; asparaginase (ASP) IV over 1 hour or intramuscularly (IM) on days 15, 18, 22, 25, 29, and 33; MTX IT on days 1 and 29\*; and ARA-C IT on day 15. Patients also receive PRDL or therapeutic hydrocortisone (HC) IT on days 1, 15, and 29.
NOTE: \*Patients with CNS involvement at initial diagnosis also receive MTX IT on days 8 and 22. If CNS leukemia is still present at day 29, then patients receive weekly MTX IT until the CNS is free of leukemia.
After completion of induction therapy, patients are stratified according to risk group (low-risk \[LR\] vs medium-risk \[MR\] vs high-risk \[HR\]). Patients with low-risk disease are assigned to treatment arm I. Patients with MR or HR disease that is in complete remission (CR) on day 33 are randomized to 1 of 2 treatment arms. These patients are stratified according to status (MR with rearranged MLL vs MR with unknown MLL vs HR).
* Arm I (standard therapy):
* Protocol IB therapy (beginning on day 36 of induction therapy): Patients receive cyclophosphamide (CPM) IV over 1 hour on days 1 and 29 and oral mercaptopurine (MP) on days 1-28; ARA-C IV on days 3-6, 10-13, 17-20, and 24-27; ARA-C IT on day 10; and MTX IT on day 24. Patients also receive PRDL or therapeutic HC IT on days 10 and 24.
* MARMA therapy:
* Part I: Patients receive oral MP once daily on days 1-14; high-dose (HD) MTX IV over 24 hours on days 1 and 8; leucovorin calcium orally or IV at 42, 48, and 54 hours after each dose of MTX until MTX plasma levels are safe; and MTX IT on days 2 and 9. Patients also receive PRDL or therapeutic HC IT on days 2 and 9.
* Part II: Patients receive HD ARA-C IV over 3 hours twice daily with 12-hour intervals on days 15, 16, 22, and 23; and pegaspargase (PEG-ASP) IV over 1 hour or IM on day 23.
* OCTADA(D) reinduction therapy:
* Part I: At least 2 weeks after the completion of MARMA chemotherapy, patients receive oral dexamethasone (DEXA) three times daily on days 1-14, followed by a taper to 0 at day 21; oral thioguanine (TG) once daily on days 1-28; VCR IV on days 1, 8, 15, and 22; DNR IV over 1 hour on days 1, 8, 15, and 22; PEG-ASP IV over 1 hour or IM on day 1; ARA-C IV on days 2-5, 9-12, 16-19, and 23-26; and ARA-C IT on days 1 and 15. Patients also receive PRDL or therapeutic HC IT on days 1 and 15.
* Part II: Patients receive oral TG once daily on days 36-49; ARA-C IV once daily on days 37-40 and 45-48; and CPM IV over 1 hour on days 36 and 49.
* Maintenance therapy: At least 2 weeks after completion of the last course of OCTADA(D) chemotherapy, patients receive oral MP once daily; oral MTX once weekly; MTX IT in weeks 1 and 15; and ARA-C IT in week 8. Patients also receive PRDL or therapeutic HC IT in weeks 1, 8, and 15. Treatment continues for up to 104 weeks after initial diagnosis in the absence of disease progression or unacceptable toxicity.
* Arm II (experimental therapy):
* ADE therapy (beginning on day 36 of induction therapy: Patients receive ARA-C IV every 12 hours on days 1-10; DNR IV over 1 hour on days 1, 3, and 5; etoposide (VP-16) IV over 4 hours on days 1-5; and ARA-C IT on day 1. Patients also receive PRDL or therapeutic HC IT on day 1.
* MAE therapy: Patients receive ARA-C IV every 12 hours on days 1-10; mitoxantrone hydrochloride IV over 1 hour on days 1, 3, and 5; VP-16 IV over 4 hours on days 1-5; and MTX IT on day 1. Patients also receive PRDL or therapeutic HC IT on day 1.
* MARMA therapy:
* Part I: Patients receive oral MP once daily on days 1-14; high-dose (HD) MTX IV over 24 hours on days 1 and 8; leucovorin calcium orally or IV at 42, 48, and 54 hours after each dose of MTX until MTX plasma levels are safe; and MTX IT on days 2 and 9. Patients also receive PRDL or therapeutic HC IT on days 2 and 9.
* Part II: Patients receive HD ARA-C IV over 3 hours twice daily with 12-hour intervals on days 15, 16, 22, and 23; and pegaspargase (PEG-ASP) IV over 1 hour or IM on day 23.
* OCTADA reinduction therapy:
* Part I: At least 2 weeks after the completion of MARMA chemotherapy, patients receive oral DEXA three times daily on days 1-14, followed by a taper to 0 at day 21; oral TG once daily on days 1-28; VCR IV on days 1, 8, 15, and 22; PEG-ASP IV over 1 hour or IM on day 1; ARA-C IV on days 2-5, 9-12, 16-19, and 23-26; and ARA-C IT on days 1 and 15. Patients also receive PRDL or therapeutic HC IT on days 1 and 15.
* Part II: Beginning 1 week after completion of part I, patients receive oral TG once daily on days 36-49; ARA-C IV once daily on days 37-40 and 45-48; and CPM IV over 1 hour on days 36 and 49.
* Maintenance therapy: At least 2 weeks after completion of the last course of OCTADA chemotherapy, patients receive oral MP once daily; oral MTX once weekly; MTX IT in weeks 1 and 15; and ARA-C IT in week 8. Patients also receive PRDL or therapeutic HC IT in weeks 1, 8, and 15. Treatment continues for up to 104 weeks after initial diagnosis in the absence of disease progression or unacceptable toxicity.
All HR patients with a suitably matched donor are scheduled for allogeneic stem cell transplantation (SCT) after MARMA or before or during OCTADA(D) chemotherapy, provided they are in CR1 and no more than 8 months have elapsed since initial diagnosis.
* Conditioning regimens for allogeneic SCT:
* Matched sibling donor (MSD): Patients receive oral busulfan (BU) every 6 hours on days -7 to -4; CPM IV over 1 hour on days -3 to -2; and melphalan (MEL) IV over 1 hour on day -1.
* Matched donors (MD): Patients receive oral BU every 6 hours on days -7 to -4; CPM IV over 1 hour on days -3 to -2; MEL IV over 1 hour on day -1; and anti-thymocyte globulin (ATG) IV over 4 hours on days -3 to -1.
* Graft-Versus-Host Disease (GVHD) prophylaxis and therapy:
* MSD: Patients receive cyclosporine (CsA) IV or orally twice daily beginning on day -1 and continuing to day 60 after SCT, followed by a taper in the absence of GVHD symptoms.
* MD: Patients receive CsA as in group MSD; MTX IV on days 1, 3, and 6; leucovorin calcium IV on days 2, 4, and 7; and ATG IV on days -3 to -1.
* Allogeneic SCT: Patients undergo infusion of bone marrow, peripheral blood, or cord blood hematopoietic stem cells on day 0.
After completion of study therapy, patients are followed periodically for up to 2 years.
Primary
* To compare an early intensification regimen comprising two "acute myeloid leukemia" induction therapy blocks with a standard protocol IB regimen administered directly after induction therapy in medium-risk (MR) and high-risk (HR) patients with newly diagnosed acute lymphoblastic or biphenotypic leukemia.
Secondary
* To compare through a randomized study the role of these regimens in treating these patients.
* To compare the overall outcome of the Interfant-06 study with outcomes in the historical control series, especially in the Interfant-99 study.
* To compare the outcomes of low-risk, MR, or HR patients in this study with those of patients in the historical control series Interfant-99 study.
* To study which factors have independent prognostic value in patients treated with these regimens.
* To assess the role of stem cell transplantation in HR patients.
OUTLINE: This is a multicenter study.
* Induction therapy:
* Prednisone phase: Patients receive prednisone orally or IV three times daily on days 1-7 and methotrexate (MTX) and prednisolone (PRDL) intrathecally (IT) on day 1. Patients then proceed to remission induction therapy.
* Remission induction phase: Patients receive dexamethasone (DEXA) IV or orally three times daily on days 8-28 followed by a taper to 0 over 1 week; vincristine (VCR) IV on days 8, 15, 22, and 29; cytarabine (ARA-C) IV over 30 minutes on days 8-21; daunorubicin hydrochloride (DNR) IV over 1 hour on days 8 and 9; asparaginase (ASP) IV over 1 hour or intramuscularly (IM) on days 15, 18, 22, 25, 29, and 33; MTX IT on days 1 and 29\*; and ARA-C IT on day 15. Patients also receive PRDL or therapeutic hydrocortisone (HC) IT on days 1, 15, and 29.
NOTE: \*Patients with CNS involvement at initial diagnosis also receive MTX IT on days 8 and 22. If CNS leukemia is still present at day 29, then patients receive weekly MTX IT until the CNS is free of leukemia.
After completion of induction therapy, patients are stratified according to risk group (low-risk \[LR\] vs medium-risk \[MR\] vs high-risk \[HR\]). Patients with low-risk disease are assigned to treatment arm I. Patients with MR or HR disease that is in complete remission (CR) on day 33 are randomized to 1 of 2 treatment arms. These patients are stratified according to status (MR with rearranged MLL vs MR with unknown MLL vs HR).
* Arm I (standard therapy):
* Protocol IB therapy (beginning on day 36 of induction therapy): Patients receive cyclophosphamide (CPM) IV over 1 hour on days 1 and 29 and oral mercaptopurine (MP) on days 1-28; ARA-C IV on days 3-6, 10-13, 17-20, and 24-27; ARA-C IT on day 10; and MTX IT on day 24. Patients also receive PRDL or therapeutic HC IT on days 10 and 24.
* MARMA therapy:
* Part I: Patients receive oral MP once daily on days 1-14; high-dose (HD) MTX IV over 24 hours on days 1 and 8; leucovorin calcium orally or IV at 42, 48, and 54 hours after each dose of MTX until MTX plasma levels are safe; and MTX IT on days 2 and 9. Patients also receive PRDL or therapeutic HC IT on days 2 and 9.
* Part II: Patients receive HD ARA-C IV over 3 hours twice daily with 12-hour intervals on days 15, 16, 22, and 23; and pegaspargase (PEG-ASP) IV over 1 hour or IM on day 23.
* OCTADA(D) reinduction therapy:
* Part I: At least 2 weeks after the completion of MARMA chemotherapy, patients receive oral dexamethasone (DEXA) three times daily on days 1-14, followed by a taper to 0 at day 21; oral thioguanine (TG) once daily on days 1-28; VCR IV on days 1, 8, 15, and 22; DNR IV over 1 hour on days 1, 8, 15, and 22; PEG-ASP IV over 1 hour or IM on day 1; ARA-C IV on days 2-5, 9-12, 16-19, and 23-26; and ARA-C IT on days 1 and 15. Patients also receive PRDL or therapeutic HC IT on days 1 and 15.
* Part II: Patients receive oral TG once daily on days 36-49; ARA-C IV once daily on days 37-40 and 45-48; and CPM IV over 1 hour on days 36 and 49.
* Maintenance therapy: At least 2 weeks after completion of the last course of OCTADA(D) chemotherapy, patients receive oral MP once daily; oral MTX once weekly; MTX IT in weeks 1 and 15; and ARA-C IT in week 8. Patients also receive PRDL or therapeutic HC IT in weeks 1, 8, and 15. Treatment continues for up to 104 weeks after initial diagnosis in the absence of disease progression or unacceptable toxicity.
* Arm II (experimental therapy):
* ADE therapy (beginning on day 36 of induction therapy: Patients receive ARA-C IV every 12 hours on days 1-10; DNR IV over 1 hour on days 1, 3, and 5; etoposide (VP-16) IV over 4 hours on days 1-5; and ARA-C IT on day 1. Patients also receive PRDL or therapeutic HC IT on day 1.
* MAE therapy: Patients receive ARA-C IV every 12 hours on days 1-10; mitoxantrone hydrochloride IV over 1 hour on days 1, 3, and 5; VP-16 IV over 4 hours on days 1-5; and MTX IT on day 1. Patients also receive PRDL or therapeutic HC IT on day 1.
* MARMA therapy:
* Part I: Patients receive oral MP once daily on days 1-14; high-dose (HD) MTX IV over 24 hours on days 1 and 8; leucovorin calcium orally or IV at 42, 48, and 54 hours after each dose of MTX until MTX plasma levels are safe; and MTX IT on days 2 and 9. Patients also receive PRDL or therapeutic HC IT on days 2 and 9.
* Part II: Patients receive HD ARA-C IV over 3 hours twice daily with 12-hour intervals on days 15, 16, 22, and 23; and pegaspargase (PEG-ASP) IV over 1 hour or IM on day 23.
* OCTADA reinduction therapy:
* Part I: At least 2 weeks after the completion of MARMA chemotherapy, patients receive oral DEXA three times daily on days 1-14, followed by a taper to 0 at day 21; oral TG once daily on days 1-28; VCR IV on days 1, 8, 15, and 22; PEG-ASP IV over 1 hour or IM on day 1; ARA-C IV on days 2-5, 9-12, 16-19, and 23-26; and ARA-C IT on days 1 and 15. Patients also receive PRDL or therapeutic HC IT on days 1 and 15.
* Part II: Beginning 1 week after completion of part I, patients receive oral TG once daily on days 36-49; ARA-C IV once daily on days 37-40 and 45-48; and CPM IV over 1 hour on days 36 and 49.
* Maintenance therapy: At least 2 weeks after completion of the last course of OCTADA chemotherapy, patients receive oral MP once daily; oral MTX once weekly; MTX IT in weeks 1 and 15; and ARA-C IT in week 8. Patients also receive PRDL or therapeutic HC IT in weeks 1, 8, and 15. Treatment continues for up to 104 weeks after initial diagnosis in the absence of disease progression or unacceptable toxicity.
All HR patients with a suitably matched donor are scheduled for allogeneic stem cell transplantation (SCT) after MARMA or before or during OCTADA(D) chemotherapy, provided they are in CR1 and no more than 8 months have elapsed since initial diagnosis.
* Conditioning regimens for allogeneic SCT:
* Matched sibling donor (MSD): Patients receive oral busulfan (BU) every 6 hours on days -7 to -4; CPM IV over 1 hour on days -3 to -2; and melphalan (MEL) IV over 1 hour on day -1.
* Matched donors (MD): Patients receive oral BU every 6 hours on days -7 to -4; CPM IV over 1 hour on days -3 to -2; MEL IV over 1 hour on day -1; and anti-thymocyte globulin (ATG) IV over 4 hours on days -3 to -1.
* Graft-Versus-Host Disease (GVHD) prophylaxis and therapy:
* MSD: Patients receive cyclosporine (CsA) IV or orally twice daily beginning on day -1 and continuing to day 60 after SCT, followed by a taper in the absence of GVHD symptoms.
* MD: Patients receive CsA as in group MSD; MTX IV on days 1, 3, and 6; leucovorin calcium IV on days 2, 4, and 7; and ATG IV on days -3 to -1.
* Allogeneic SCT: Patients undergo infusion of bone marrow, peripheral blood, or cord blood hematopoietic stem cells on day 0.
After completion of study therapy, patients are followed periodically for up to 2 years.
Conditions
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Leukemia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Interventions
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anti-thymocyte globulin
Intervention Type
BIOLOGICAL
asparaginase
Intervention Type
DRUG
busulfan
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
cyclosporine
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
leucovorin calcium
Intervention Type
DRUG
melphalan
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
mitoxantrone hydrochloride
Intervention Type
DRUG
pegaspargase
Intervention Type
DRUG
prednisolone
Intervention Type
DRUG
prednisone
Intervention Type
DRUG
therapeutic hydrocortisone
Intervention Type
DRUG
thioguanine
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
allogeneic bone marrow transplantation
Intervention Type
PROCEDURE
allogeneic hematopoietic stem cell transplantation
Intervention Type
PROCEDURE
umbilical cord blood transplantation
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute lymphoblastic leukemia (ALL) or biphenotypic leukemia meeting the following criteria:
* Based on European Group for the Classification of Acute Leukemia (EGIL) diagnostic criteria
* Newly diagnosed disease
* Verified by morphology and confirmed by cytochemistry and immunophenotyping
* Trephine biopsy is recommended (unless diagnosis can be confirmed by peripheral blood examination) in the event that bone marrow aspiration results in a "dry tap"
* Must have MLL gene rearrangements documented by split-signal fluorescence in situ hybridization and meets 1 of the following risk criteria:
* Low-risk disease, defined as all MLL germline cases
* Medium-risk disease, defined by 1 of the following criteria:
* MLL status unknown
* MLL rearranged AND age \> 6 months
* MLL rearranged AND age \< 6 months AND WBC \< 300 x 10\^9/L AND prednisone good response
* High-risk disease, defined by MLL rearrangement AND meets the following criteria:
* Age at diagnosis \< 6 months (i.e., \< 183 days)
* WBC ≥ 300 x 10\^9/L AND/OR prednisone poor response
* Minimum donor and stem cell requirements for high-risk patients undergoing stem cell transplantation:
* Donor meeting 1 of the following criteria:
* HLA-identical sibling
* Very well-matched related or unrelated donor
* Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping
* Stem cell source
* Bone marrow (preferred source) OR peripheral blood stem cells of filgrastim \[G-CSF\]-stimulated donors OR cord blood
* Highly-matched unrelated umbilical cord blood (UCB) (\> 7/8 matches identified by high-resolution typing) accepted if a sibling donor is not able to donate bone marrow AND UCB with a sufficient number of nucleated cells (NCs) (i.e., \> 1.5 x 10\^7/kg recipient body weight \[BW\]) is cryopreserved
* Must have ≥ 3 x 10\^8 NCs/kg BW OR 3 x 10\^6/kg BW CD34-positive cells available for transplantation
* CNS or testicular leukemia at diagnosis allowed
* Based on European Group for the Classification of Acute Leukemia (EGIL) diagnostic criteria
* Newly diagnosed disease
* Verified by morphology and confirmed by cytochemistry and immunophenotyping
* Trephine biopsy is recommended (unless diagnosis can be confirmed by peripheral blood examination) in the event that bone marrow aspiration results in a "dry tap"
* Must have MLL gene rearrangements documented by split-signal fluorescence in situ hybridization and meets 1 of the following risk criteria:
* Low-risk disease, defined as all MLL germline cases
* Medium-risk disease, defined by 1 of the following criteria:
* MLL status unknown
* MLL rearranged AND age \> 6 months
* MLL rearranged AND age \< 6 months AND WBC \< 300 x 10\^9/L AND prednisone good response
* High-risk disease, defined by MLL rearrangement AND meets the following criteria:
* Age at diagnosis \< 6 months (i.e., \< 183 days)
* WBC ≥ 300 x 10\^9/L AND/OR prednisone poor response
* Minimum donor and stem cell requirements for high-risk patients undergoing stem cell transplantation:
* Donor meeting 1 of the following criteria:
* HLA-identical sibling
* Very well-matched related or unrelated donor
* Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping
* Stem cell source
* Bone marrow (preferred source) OR peripheral blood stem cells of filgrastim \[G-CSF\]-stimulated donors OR cord blood
* Highly-matched unrelated umbilical cord blood (UCB) (\> 7/8 matches identified by high-resolution typing) accepted if a sibling donor is not able to donate bone marrow AND UCB with a sufficient number of nucleated cells (NCs) (i.e., \> 1.5 x 10\^7/kg recipient body weight \[BW\]) is cryopreserved
* Must have ≥ 3 x 10\^8 NCs/kg BW OR 3 x 10\^6/kg BW CD34-positive cells available for transplantation
* CNS or testicular leukemia at diagnosis allowed
Exclusion Criteria
* Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL
* Presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if data are not known, patient still may be eligible)
* Relapsed ALL
PATIENT CHARACTERISTICS:
* See Disease Characteristics
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior systemic corticosteroids
* Corticosteroids by aerosol are allowed
* Presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if data are not known, patient still may be eligible)
* Relapsed ALL
PATIENT CHARACTERISTICS:
* See Disease Characteristics
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior systemic corticosteroids
* Corticosteroids by aerosol are allowed
Maximum Eligible Age
1 Year
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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BFM Germany
UNKNOWN
Sponsor Role
collaborator
CORS Monza Italy
UNKNOWN
Sponsor Role
collaborator
Associazione Italiana Ematologia Oncologia Pediatrica
OTHER
Sponsor Role
collaborator
Australian and New Zealand Children's Oncology Group
OTHER
Sponsor Role
collaborator
BFM Austria
UNKNOWN
Sponsor Role
collaborator
CLCG France Belgium Portugal
UNKNOWN
Sponsor Role
collaborator
COALL Germany
UNKNOWN
Sponsor Role
collaborator
CPH, Czech republic
UNKNOWN
Sponsor Role
collaborator
DFCI consortium USA
UNKNOWN
Sponsor Role
collaborator
FRALLE France
UNKNOWN
Sponsor Role
collaborator
Hong Kong Government
OTHER_GOV
Sponsor Role
collaborator
MD Anderson USA
UNKNOWN
Sponsor Role
collaborator
NOPHO Scandinavian countries
UNKNOWN
Sponsor Role
collaborator
PINDA, Chile
UNKNOWN
Sponsor Role
collaborator
PPLLSG Poland
UNKNOWN
Sponsor Role
collaborator
Seattle USA
UNKNOWN
Sponsor Role
collaborator
SJCRH USA
UNKNOWN
Sponsor Role
collaborator
UKCCSG United Kingdom
UNKNOWN
Sponsor Role
collaborator
Dutch Childhood Oncology Group
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Rob Pieters, MD, MSC, PhD
Role: STUDY_CHAIR
Prinses Maxima Centrum voor kinderoncologie Utrecht
Martin Schrappe, MD, PhD
Role: STUDY_CHAIR
University Hospital Schleswig-Holstein
Locations
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Children's Hospital Boston
Boston, Massachusetts, United States
Site Status
RECRUITING
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Site Status
RECRUITING
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Site Status
RECRUITING
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Site Status
RECRUITING
St. Anna Children's Hospital
Vienna, , Austria
Site Status
RECRUITING
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, , Belgium
Site Status
RECRUITING
University Hospital Motol
Prague, , Czechia
Site Status
RECRUITING
CHR Hotel Dieu
Nantes, , France
Site Status
RECRUITING
University Medical Center Hamburg - Eppendorf
Hamburg, , Germany
Site Status
RECRUITING
Medizinische Hochschule Hannover
Hanover, , Germany
Site Status
RECRUITING
Nuovo Ospedale San Gerardo at University of Milano-Bicocca
Monza, , Italy
Site Status
RECRUITING
Erasmus MC - Sophia Children's Hospital
Rotterdam, , Netherlands
Site Status
RECRUITING
Great Ormond Street Hospital for Children
London, England, United Kingdom
Site Status
RECRUITING
Countries
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United States
Austria
Belgium
Czechia
France
Germany
Italy
Netherlands
United Kingdom
Facility Contacts
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Lewis B. Silverman, MD
Role: primary
617-632-5285
Clinical Trials Office - St. Jude Children's Research Hospital
Role: primary
901-595-4644
Clinical Trials Office - M. D. Anderson Cancer Center at the U
Role: primary
713-792-3245
Blythe Thomson, MD
Role: primary
206-987-2106
Georg Mann, MD
Role: primary
43-1-4017-1250
Francoise Mechinaud, MD
Role: primary
33-1-4249-9046
Gritta Janka-Schaub
Role: primary
49-404-2803-2580
Martin Schrappe, MD, PhD
Role: primary
49-511-532-6713
Phil Ancliff, MD
Role: primary
44-20-7829-8831
References
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Stutterheim J, van der Sluis IM, de Lorenzo P, Alten J, Ancliffe P, Attarbaschi A, Brethon B, Biondi A, Campbell M, Cazzaniga G, Escherich G, Ferster A, Kotecha RS, Lausen B, Li CK, Lo Nigro L, Locatelli F, Marschalek R, Meyer C, Schrappe M, Stary J, Vora A, Zuna J, van der Velden VHJ, Szczepanski T, Valsecchi MG, Pieters R. Clinical Implications of Minimal Residual Disease Detection in Infants With KMT2A-Rearranged Acute Lymphoblastic Leukemia Treated on the Interfant-06 Protocol. J Clin Oncol. 2021 Feb 20;39(6):652-662. doi: 10.1200/JCO.20.02333. Epub 2021 Jan 6.
Reference Type
DERIVED
Pieters R, De Lorenzo P, Ancliffe P, Aversa LA, Brethon B, Biondi A, Campbell M, Escherich G, Ferster A, Gardner RA, Kotecha RS, Lausen B, Li CK, Locatelli F, Attarbaschi A, Peters C, Rubnitz JE, Silverman LB, Stary J, Szczepanski T, Vora A, Schrappe M, Valsecchi MG. Outcome of Infants Younger Than 1 Year With Acute Lymphoblastic Leukemia Treated With the Interfant-06 Protocol: Results From an International Phase III Randomized Study. J Clin Oncol. 2019 Sep 1;37(25):2246-2256. doi: 10.1200/JCO.19.00261. Epub 2019 Jul 8.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DCOG-INTERFANT-06
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-004599-19
Identifier Type: -
Identifier Source: secondary_id
CCLG-LK-2006-10
Identifier Type: -
Identifier Source: secondary_id
CDR0000570260
Identifier Type: -
Identifier Source: org_study_id
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