Standard Chemotherapy with or Without Nelarabine or Rituximab in Treating Patients with Newly Diagnosed Acute Lymphoblastic Leukemia
NCT ID: NCT01085617
Last Updated: 2025-03-30
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
COMPLETED
Study Classification
INTERVENTIONAL
Study Start Date
2010-12-31
Study Completion Date
2025-02-24
Brief Summary
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known which regimen of combination chemotherapy given together with or without monoclonal antibodies is more effective in treating patients with newly diagnosed acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying standard chemotherapy to see how well it works when given together with or without rituximab, and with or without nelarabine in treating patients with newly diagnosed acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying standard chemotherapy to see how well it works when given together with or without rituximab, and with or without nelarabine in treating patients with newly diagnosed acute lymphoblastic leukemia.
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Detailed Description
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OBJECTIVES:
Primary
* To determine if the addition of a monoclonal antibody (none vs. rituximab) improves event-free survival (EFS) in patients with newly diagnosed precursor B-cell acute lymphoblastic leukemia (ALL).
* To determine if the addition of nelarabine improves outcome for patients with T-cell ALL.
Secondary
* To determine the tolerability of pegaspargase in induction therapy of all patients.
* To compare anti-asparaginase antibody levels in patients with B-lineage ALL.
* To determine whether risk-adapted introduction of unrelated donor hematopoietic stem cell transplantation (HSCT) (myeloablative conditioning in patients ≤ 40 years old and non-myeloablative conditioning in patients \> 40 years old) results in greater EFS for patients at highest risk of relapse.
* To compare the efficacy of two schedules (standard vs collapsed) of palifermin in preventing severe mucosal toxicity in patients treated with etoposide, total-body irradiation, and HSCT-conditioning therapy.
* To assess the late effects of this treatment in these patients.
* To identify and describe some of the adverse physical and psychosocial consequences of this disease and its treatment.
OUTLINE: This is a multicenter study. There are 3 randomizations at different timepoints in the trial, each patient undergoes at least 1 but no more than 2 randomizations.
* Part 1 standard induction therapy (all patients\*, weeks 1-4): Patients receive daunorubicin hydrochloride IV over 20 minutes and vincristine sulfate IV over 5-10 minutes on days 1, 8, 15, and 22; oral dexamethasone once a day on days 1-5, 8-11, and 15-18; pegaspargase IV over 1-2 hours on days 4 and 18; and methotrexate intrathecally (IT) on day 14.
NOTE: \*Patients with Philadelphia-positive (Ph+) disease should also receive oral imatinib mesylate once a day on days 1-28.
* Randomized concurrent monoclonal antibody therapy (for patients with precursor B-cell acute lymphoblastic leukemia \[ALL\]): Patients with precursor B-cell ALL are randomized to 1 of 4 monoclonal antibody treatment arms (given concurrently with part 1 standard induction therapy):
* Arm B1: Patients do not receive any monoclonal antibody therapy.
* Arm B2 : Patients receive rituximab IV on days 3, 10, 17, and 24.
* Part 2 standard induction therapy (all patients\*, weeks 5-8): Patients receive cyclophosphamide IV over 30 minutes on days 1 and 15; cytarabine IV on days 2-5, 9-12, 16-19, and 23-26; oral mercaptopurine once a day on days 1-28; and methotrexate IT on days 1, 8, 15, and 22.
NOTE: \*Patients with Ph+ disease should also receive oral imatinib mesylate once a day on days 1-30.
* Randomized subsequent nelarabine therapy (for Patients with T-cell ALL) Patients with T-cell ALL are randomized to 1 of 2 treatment arms, to be administered after completion of part 2 standard induction therapy.
* Arm T1: Patients do not receive any other therapy during induction.
* Arm T2: Patients receive nelarabine IV over 2 hours on days 1, 3, and 5. Patients who do not achieve complete remission (CR) after part 2 standard induction therapy are taken off study.
* Intensification/central nervous system prophylaxis (patients not eligible for transplant OR patients \> 40 years at study entry and eligible for transplant)\*: Beginning after recovery from part 2 standard induction therapy, patients receive high-dose methotrexate IV on days 1 and 15 and pegaspargase IV over 1-2 hours on days 2 and 16.
NOTE: \*Patients with Philadelphia-positive (Ph+) disease should also receive oral imatinib mesylate once a day on days 1-28.
Patients eligible for allogeneic hematopoietic stem cell transplantation (HSCT) (i.e., any patient with an HLA-compatible sibling donor or high risk patients with a molecularly matched donor) undergo transplantation; patients not eligible for HSCT undergo consolidation followed by maintenance therapy.
* Consolidation therapy\* (patients not eligible for transplantation):
* Course 1: Beginning after completion of intensification therapy, patients receive cytarabine IV and high-dose etoposide IV over 30 minutes on days 1-5, pegaspargase IV over 1-2 hours on day 5, and methotrexate IT on day 1. Patients proceed to course 2 beginning 3 weeks after the start of course 1 or when neutrophils recover.
* Course 2: Patients receive cytarabine IV and high-dose etoposide IV over 30 minutes on days 1-5 and methotrexate IT on day 1. Patients proceed to course 3 beginning 3 weeks after the start of course 2 or when neutrophils recover.
* Course 3 (delayed intensification): Patients receive daunorubicin hydrochloride IV over 20 minutes and vincristine sulfate IV over 5-10 minutes on days 1, 8, 15, and 22; pegaspargase IV over 1-2 hours on day 4; oral dexamethasone once a day on days 1-4, 8-11, 15-18, and 22-25; methotrexate IT on days 2 and 17; cyclophosphamide IV on day 29; cytarabine IV on days 30-33 and 37-40; and oral mercaptopurine once a day on days 29-42. Patients proceed to course 4 after neutrophils recover.
* Course 4: Patients receive cytarabine IV, high-dose etoposide IV, and methotrexate IT as in course 2.
NOTE: \*Patients with Ph+ disease should also receive oral imatinib mesylate once a day on days 1-7 in courses 1 and 2, on days 2-42 in course 3, and on days 1-8 in course 4.
* Maintenance therapy (patients not eligible for transplantation): Patients receive vincristine sulfate IV every 3 months, oral prednisolone once a day on days 1-5 every 3 months, oral mercaptopurine once daily, methotrexate IV or orally once a week, and methotrexate IT every 3 months for 2 years.
* Transplant conditioning and allogeneic HSCT:
* Myeloablative-conditioning and allogeneic HSCT (patients ≤ 40 years old at study entry): Patients undergo total-body irradiation on days -7 to -4 and receive high-dose etoposide IV over 4 hours on day -3 or high-dose cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo allogeneic HSCT on day 0.
Patients are stratified according to gender, donor (sibling donor vs. matched unrelated donor), and cellular type of ALL (precursor B-lineage vs. T-lineage). Patients are randomized to receive 1 of 2 palifermin treatment arms.
* Arm P1 (standard dose): Patients receive palifermin IV on days -3 to 2.
* Arm P2 (collapsed dose): Patients receive palifermin IV on days -1 to 2.
* Non-myeloablative-conditioning and allogeneic HSCT (patients \> 40 years old at study entry): Patients receive fludarabine phosphate IV over 30-60 minutes on days -7 to -3 and melphalan IV over 90 days on day -1. Recipients of unrelated donor HSCT also receive alemtuzumab IV over 2 hours on day -2 and -1; recipients of sibling HSCT receive alemtuzumab IV over 2 hours on day -1. Patients then undergo allogeneic HSCT on day 0. Patients also receive post transplant methotrexate IT every 3 months for 2 years.
Patients undergo blood and bone marrow sample collection periodically for correlative studies.
After completion of study treatment, patients are followed annually.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Primary
* To determine if the addition of a monoclonal antibody (none vs. rituximab) improves event-free survival (EFS) in patients with newly diagnosed precursor B-cell acute lymphoblastic leukemia (ALL).
* To determine if the addition of nelarabine improves outcome for patients with T-cell ALL.
Secondary
* To determine the tolerability of pegaspargase in induction therapy of all patients.
* To compare anti-asparaginase antibody levels in patients with B-lineage ALL.
* To determine whether risk-adapted introduction of unrelated donor hematopoietic stem cell transplantation (HSCT) (myeloablative conditioning in patients ≤ 40 years old and non-myeloablative conditioning in patients \> 40 years old) results in greater EFS for patients at highest risk of relapse.
* To compare the efficacy of two schedules (standard vs collapsed) of palifermin in preventing severe mucosal toxicity in patients treated with etoposide, total-body irradiation, and HSCT-conditioning therapy.
* To assess the late effects of this treatment in these patients.
* To identify and describe some of the adverse physical and psychosocial consequences of this disease and its treatment.
OUTLINE: This is a multicenter study. There are 3 randomizations at different timepoints in the trial, each patient undergoes at least 1 but no more than 2 randomizations.
* Part 1 standard induction therapy (all patients\*, weeks 1-4): Patients receive daunorubicin hydrochloride IV over 20 minutes and vincristine sulfate IV over 5-10 minutes on days 1, 8, 15, and 22; oral dexamethasone once a day on days 1-5, 8-11, and 15-18; pegaspargase IV over 1-2 hours on days 4 and 18; and methotrexate intrathecally (IT) on day 14.
NOTE: \*Patients with Philadelphia-positive (Ph+) disease should also receive oral imatinib mesylate once a day on days 1-28.
* Randomized concurrent monoclonal antibody therapy (for patients with precursor B-cell acute lymphoblastic leukemia \[ALL\]): Patients with precursor B-cell ALL are randomized to 1 of 4 monoclonal antibody treatment arms (given concurrently with part 1 standard induction therapy):
* Arm B1: Patients do not receive any monoclonal antibody therapy.
* Arm B2 : Patients receive rituximab IV on days 3, 10, 17, and 24.
* Part 2 standard induction therapy (all patients\*, weeks 5-8): Patients receive cyclophosphamide IV over 30 minutes on days 1 and 15; cytarabine IV on days 2-5, 9-12, 16-19, and 23-26; oral mercaptopurine once a day on days 1-28; and methotrexate IT on days 1, 8, 15, and 22.
NOTE: \*Patients with Ph+ disease should also receive oral imatinib mesylate once a day on days 1-30.
* Randomized subsequent nelarabine therapy (for Patients with T-cell ALL) Patients with T-cell ALL are randomized to 1 of 2 treatment arms, to be administered after completion of part 2 standard induction therapy.
* Arm T1: Patients do not receive any other therapy during induction.
* Arm T2: Patients receive nelarabine IV over 2 hours on days 1, 3, and 5. Patients who do not achieve complete remission (CR) after part 2 standard induction therapy are taken off study.
* Intensification/central nervous system prophylaxis (patients not eligible for transplant OR patients \> 40 years at study entry and eligible for transplant)\*: Beginning after recovery from part 2 standard induction therapy, patients receive high-dose methotrexate IV on days 1 and 15 and pegaspargase IV over 1-2 hours on days 2 and 16.
NOTE: \*Patients with Philadelphia-positive (Ph+) disease should also receive oral imatinib mesylate once a day on days 1-28.
Patients eligible for allogeneic hematopoietic stem cell transplantation (HSCT) (i.e., any patient with an HLA-compatible sibling donor or high risk patients with a molecularly matched donor) undergo transplantation; patients not eligible for HSCT undergo consolidation followed by maintenance therapy.
* Consolidation therapy\* (patients not eligible for transplantation):
* Course 1: Beginning after completion of intensification therapy, patients receive cytarabine IV and high-dose etoposide IV over 30 minutes on days 1-5, pegaspargase IV over 1-2 hours on day 5, and methotrexate IT on day 1. Patients proceed to course 2 beginning 3 weeks after the start of course 1 or when neutrophils recover.
* Course 2: Patients receive cytarabine IV and high-dose etoposide IV over 30 minutes on days 1-5 and methotrexate IT on day 1. Patients proceed to course 3 beginning 3 weeks after the start of course 2 or when neutrophils recover.
* Course 3 (delayed intensification): Patients receive daunorubicin hydrochloride IV over 20 minutes and vincristine sulfate IV over 5-10 minutes on days 1, 8, 15, and 22; pegaspargase IV over 1-2 hours on day 4; oral dexamethasone once a day on days 1-4, 8-11, 15-18, and 22-25; methotrexate IT on days 2 and 17; cyclophosphamide IV on day 29; cytarabine IV on days 30-33 and 37-40; and oral mercaptopurine once a day on days 29-42. Patients proceed to course 4 after neutrophils recover.
* Course 4: Patients receive cytarabine IV, high-dose etoposide IV, and methotrexate IT as in course 2.
NOTE: \*Patients with Ph+ disease should also receive oral imatinib mesylate once a day on days 1-7 in courses 1 and 2, on days 2-42 in course 3, and on days 1-8 in course 4.
* Maintenance therapy (patients not eligible for transplantation): Patients receive vincristine sulfate IV every 3 months, oral prednisolone once a day on days 1-5 every 3 months, oral mercaptopurine once daily, methotrexate IV or orally once a week, and methotrexate IT every 3 months for 2 years.
* Transplant conditioning and allogeneic HSCT:
* Myeloablative-conditioning and allogeneic HSCT (patients ≤ 40 years old at study entry): Patients undergo total-body irradiation on days -7 to -4 and receive high-dose etoposide IV over 4 hours on day -3 or high-dose cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo allogeneic HSCT on day 0.
Patients are stratified according to gender, donor (sibling donor vs. matched unrelated donor), and cellular type of ALL (precursor B-lineage vs. T-lineage). Patients are randomized to receive 1 of 2 palifermin treatment arms.
* Arm P1 (standard dose): Patients receive palifermin IV on days -3 to 2.
* Arm P2 (collapsed dose): Patients receive palifermin IV on days -1 to 2.
* Non-myeloablative-conditioning and allogeneic HSCT (patients \> 40 years old at study entry): Patients receive fludarabine phosphate IV over 30-60 minutes on days -7 to -3 and melphalan IV over 90 days on day -1. Recipients of unrelated donor HSCT also receive alemtuzumab IV over 2 hours on day -2 and -1; recipients of sibling HSCT receive alemtuzumab IV over 2 hours on day -1. Patients then undergo allogeneic HSCT on day 0. Patients also receive post transplant methotrexate IT every 3 months for 2 years.
Patients undergo blood and bone marrow sample collection periodically for correlative studies.
After completion of study treatment, patients are followed annually.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Conditions
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Leukemia
Mucositis
Oral Complications
Study Groups
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B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
Group Type
ACTIVE_COMPARATOR
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
fludarabine phosphate
Intervention Type
DRUG
imatinib mesylate
Intervention Type
DRUG
melphalan
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
pegaspargase
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
Group Type
EXPERIMENTAL
rituximab
Intervention Type
BIOLOGICAL
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
fludarabine phosphate
Intervention Type
DRUG
imatinib mesylate
Intervention Type
DRUG
melphalan
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
pegaspargase
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
Group Type
ACTIVE_COMPARATOR
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
fludarabine phosphate
Intervention Type
DRUG
melphalan
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
pegaspargase
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
Group Type
EXPERIMENTAL
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
fludarabine phosphate
Intervention Type
DRUG
melphalan
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
nelarabine
Intervention Type
DRUG
pegaspargase
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
P1 - standard palifermin
6 doses of palifermin before/after myeloablative stem cell transplant (randomisation closed due to lack of clinical relevance in 2016)
Group Type
ACTIVE_COMPARATOR
palifermin
Intervention Type
BIOLOGICAL
allogeneic hematopoietic stem cell transplantation
Intervention Type
PROCEDURE
total-body irradiation
Intervention Type
RADIATION
P2 - collapsed palifermin
1 x large dose of palifermin before myeloablative stem cell transplant and 3 low doses after transplant (randomisation closed due to lack of clinical relevance in 2016)
Group Type
EXPERIMENTAL
palifermin
Intervention Type
BIOLOGICAL
allogeneic hematopoietic stem cell transplantation
Intervention Type
PROCEDURE
total-body irradiation
Intervention Type
RADIATION
Interventions
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palifermin
Intervention Type
BIOLOGICAL
rituximab
Intervention Type
BIOLOGICAL
cyclophosphamide
Intervention Type
DRUG
cytarabine
Intervention Type
DRUG
daunorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
fludarabine phosphate
Intervention Type
DRUG
imatinib mesylate
Intervention Type
DRUG
melphalan
Intervention Type
DRUG
mercaptopurine
Intervention Type
DRUG
methotrexate
Intervention Type
DRUG
nelarabine
Intervention Type
DRUG
pegaspargase
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
allogeneic hematopoietic stem cell transplantation
Intervention Type
PROCEDURE
total-body irradiation
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion Criteria
* No blast transformation of chronic myeloid leukemia
* No mature B-cell leukemia \[i.e., Burkitt disease t(8,14)(q24 ;q32)\] or variant c-myc translocations \[e.g., t(2;8)(p12;q24), t(8;22)(q24;q11)\]
* Patients who undergo study transplantation must have HLA-compatible sibling or unrelated donor
* 8/8 molecular match at -A, -B, -C, and -DR (DQ mismatch is permitted)
* Patients meeting ≥ 1 the following criteria are considered high-risk:
* Over 40 years old
* WBC ≥ 30 x 10\^9/L (precursor-B) OR ≥ 100 x 10\^9/L (T-lineage)
* Any 1 or more of the following cytogenetic abnormalities:
* t(4;11)(q21;q23)/MLL-AF4
* Low hypodiploidy/near triploidy (30-39 chromosomes/60-78 chromosomes)
* Complex karyotype (≥ 5 chromosomal abnormalities)
* Philadelphia chromosome t(9;22) (q34;q11)/BCR-ABL1 (detected by cytogenetic or molecular methods)
* High-risk minimal-residual disease after completion of part 2 standard induction therapy
PATIENT CHARACTERISTICS:
* No known HIV infection
* Not pregnant or nursing (no nursing during and for 12 months after completion of study therapy)
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 12 months after completion of study therapy
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No mature B-cell leukemia \[i.e., Burkitt disease t(8,14)(q24 ;q32)\] or variant c-myc translocations \[e.g., t(2;8)(p12;q24), t(8;22)(q24;q11)\]
* Patients who undergo study transplantation must have HLA-compatible sibling or unrelated donor
* 8/8 molecular match at -A, -B, -C, and -DR (DQ mismatch is permitted)
* Patients meeting ≥ 1 the following criteria are considered high-risk:
* Over 40 years old
* WBC ≥ 30 x 10\^9/L (precursor-B) OR ≥ 100 x 10\^9/L (T-lineage)
* Any 1 or more of the following cytogenetic abnormalities:
* t(4;11)(q21;q23)/MLL-AF4
* Low hypodiploidy/near triploidy (30-39 chromosomes/60-78 chromosomes)
* Complex karyotype (≥ 5 chromosomal abnormalities)
* Philadelphia chromosome t(9;22) (q34;q11)/BCR-ABL1 (detected by cytogenetic or molecular methods)
* High-risk minimal-residual disease after completion of part 2 standard induction therapy
PATIENT CHARACTERISTICS:
* No known HIV infection
* Not pregnant or nursing (no nursing during and for 12 months after completion of study therapy)
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 12 months after completion of study therapy
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Minimum Eligible Age
25 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University College, London
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Adele K. Fielding
Role: PRINCIPAL_INVESTIGATOR
University of York
References
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Marks DI, Clifton-Hadley L, Copland M, Hussain J, Menne TF, McMillan A, Moorman AV, Morley N, Okasha D, Patel B, Patrick P, Potter MN, Rowntree CJ, Kirkwood AA, Fielding AK. In-vivo T-cell depleted reduced-intensity conditioned allogeneic haematopoietic stem-cell transplantation for patients with acute lymphoblastic leukaemia in first remission: results from the prospective, single-arm evaluation of the UKALL14 trial. Lancet Haematol. 2022 Apr;9(4):e276-e288. doi: 10.1016/S2352-3026(22)00036-9.
Reference Type
DERIVED
Marks DI, Kirkwood AA, Rowntree CJ, Aguiar M, Bailey KE, Beaton B, Cahalin P, Castleton AZ, Clifton-Hadley L, Copland M, Goldstone AH, Kelly R, Lawrie E, Lee S, McMillan AK, McMullin MF, Menne TF, Mitchell RJ, Moorman AV, Patel B, Patrick P, Smith P, Taussig D, Yallop D, Alapi KZ, Fielding AK. Addition of four doses of rituximab to standard induction chemotherapy in adult patients with precursor B-cell acute lymphoblastic leukaemia (UKALL14): a phase 3, multicentre, randomised controlled trial. Lancet Haematol. 2022 Apr;9(4):e262-e275. doi: 10.1016/S2352-3026(22)00038-2.
Reference Type
DERIVED
Mitchell RJ, Kirkwood AA, Barretta E, Clifton-Hadley L, Lawrie E, Lee S, Leongamornlert D, Marks DI, McMillan AK, Menne TF, Papaemmanuil E, Patel B, Patrick P, Rowntree CJ, Zareian N, Alapi KZ, Moorman AV, Fielding AK. IKZF1 alterations are not associated with outcome in 498 adults with B-precursor ALL enrolled in the UKALL14 trial. Blood Adv. 2021 Sep 14;5(17):3322-3332. doi: 10.1182/bloodadvances.2021004430.
Reference Type
DERIVED
Patel B, Kirkwood AA, Dey A, Marks DI, McMillan AK, Menne TF, Micklewright L, Patrick P, Purnell S, Rowntree CJ, Smith P, Fielding AK. Pegylated-asparaginase during induction therapy for adult acute lymphoblastic leukaemia: toxicity data from the UKALL14 trial. Leukemia. 2017 Jan;31(1):58-64. doi: 10.1038/leu.2016.219. Epub 2016 Aug 2.
Reference Type
DERIVED
Other Identifiers
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UCL-08-0167
Identifier Type: OTHER
Identifier Source: secondary_id
EU-21009
Identifier Type: OTHER
Identifier Source: secondary_id
2009-012717-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UCL-UKALL14
Identifier Type: OTHER
Identifier Source: secondary_id
MREC-09-H0711-90
Identifier Type: OTHER
Identifier Source: secondary_id
NCRI-UCL-08-0167
Identifier Type: OTHER
Identifier Source: secondary_id
CRUK-C27995-A9609
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CDR0000667211
Identifier Type: -
Identifier Source: org_study_id
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Decitabine, Donor Natural Killer Cells, and Aldesleukin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT02316964
COMPLETED
PHASE1
Lenalidomide Plus Chemotherapy for AML
NCT01681537
COMPLETED
PHASE1
Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT00002805
COMPLETED
PHASE2
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
NCT04293562
RECRUITING
PHASE3
Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
NCT00002693
COMPLETED
PHASE1
Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
NCT00186381
COMPLETED
PHASE2
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
NCT00458848
COMPLETED
PHASE2
Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT01249430
COMPLETED
PHASE1
Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
NCT00004218
COMPLETED
PHASE3
Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission
NCT00002514
COMPLETED
PHASE3
Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT00003268
COMPLETED
PHASE1