Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant
NCT ID: NCT02333162
Last Updated: 2025-02-05
Study Results
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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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2014-12-05
2028-12-01
Brief Summary
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A Dose Escalation Study of Intensity Modulated Total Marrow Irradiation (IMRT-TMI) Followed by Fludarabine as a Myeloablative Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed and Refractory Hematologic Malignancies
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Detailed Description
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I. The determine the maximum tolerated dose (MTD) of intensity-modulate total marrow irradiation (IMTMI) in combination with fludarabine (fludarabine phosphate)/melphalan as conditioning for second allogeneic stem cell transplantation for patients with hematologic malignancies.
SECONDARY OBJECTIVES:
I. To determine the overall toxicity and day 100 transplant related mortality after second allogeneic hematopoietic stem cell transplantation conditioned with increasing doses of intensity-modulate total marrow irradiation (IMTMI) in combination with fludarabine/melphalan.
II. To determine the time to neutrophil and platelet engraftment after second allogeneic hematopoietic stem cell transplantation conditioned with increasing doses of intensity-modulate total marrow irradiation (IMTMI) in combination with fludarabine/melphalan.
III. To determine the overall survival (OS) and event-free-survival (EFS) in patients with hematologic undergoing second allogeneic hematopoietic stem cell transplant (HSCT) after conditioning with fludarabine/melphalan and IMTMI.
OUTLINE: This is a dose-escalation study of IMTMI.
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes daily on days -7 to -3 and melphalan IV on day -2. Patients also undergo IMTMI twice daily (BID) for 2 to 5 days between days -7 to -3.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) or bone marrow transplant (BMT) on day 0.
GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or orally (PO) BID on days -2 to 180 with taper thereafter and mycophenolate mofetil IV every 8 hours or PO on days 0-28 (for matched donors) or days 0-40 (for alternative donors) with taper to day 60.
After completion of treatment, patients are followed up periodically for 1 year and then yearly for 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (IMTMI, combination chemotherapy, PBSCT or BMT)
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes daily on days -7 to -3 and melphalan IV on day -2. Patients also undergo IMTMI BID for 2 to 5 days between days -7 to -3.
TRANSPLANT: Patients undergo allogeneic PBSCT or BMT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO BID on days -2 to 180 with taper thereafter and mycophenolate mofetil IV every 8 hours or PO on days 0-28 (for matched donors) or days 0-40 (for alternative donors) with taper to day 60.
Fludarabine Phosphate
Given IV
Melphalan
Given IV
Intensity-Modulated Radiation Therapy
Undergo IMTMI
Total Marrow Irradiation
Undergo IMTMI
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation
Undergo allogeneic PBSCT
Allogeneic Bone Marrow Transplantation
Undergo allogeneic BMT
Tacrolimus
Given IV or PO
Mycophenolate Mofetil
Given IV or PO
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Fludarabine Phosphate
Given IV
Melphalan
Given IV
Intensity-Modulated Radiation Therapy
Undergo IMTMI
Total Marrow Irradiation
Undergo IMTMI
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation
Undergo allogeneic PBSCT
Allogeneic Bone Marrow Transplantation
Undergo allogeneic BMT
Tacrolimus
Given IV or PO
Mycophenolate Mofetil
Given IV or PO
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Karnofsky performance status of 70 or above
* Life expectancy is not severely limited by concomitant illness
* Adequate cardiac and pulmonary function; patients with decreased left ventricular ejection fraction (LVEF) =\< 40% or diffusion capacity of carbon monoxide (DLCO) =\< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
* Serum creatinine =\<1.5 mg/dL or creatinine clearance \> 50 ml/min; some patients with minor deviations may be accepted on protocol after discussion with the principal investigator (PI)
* Serum bilirubin =\< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the PI
* Serum glutamic oxaloacetic transaminase (SGPT) \< 5 x upper limit of normal; some patients with minor deviations may be accepted on protocol after discussion with the PI
* No evidence of chronic active hepatitis or cirrhosis
* Human immunodeficiency virus (HIV)-negative
* Patient is not pregnant
* Patient or guardian able to sign informed consent
* DONOR: Since these patients already had first allo-SCT; in the majority time, the same matched donor has been used for second allo-SCT; if the patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-SCT; the donor could be matched related donors or matched unrelated donors from registry
* DONOR: If more than one potential volunteer unrelated donor is considered suitable, further selection of the most suitable donor will be prioritized as follows or will follow our institutional guideline from our stem cell transplant standard operating procedure (SOP):
* Age of donor (18-24 \> 25-34 \> 35-44 \> 45+)
* Sex of donor (male \> female, nulliparous female \> parous, multiparous female)
* Cytomegalovirus (CMV) status, if recipient is CMV seronegative (CMV- \> CMV+
18 Years
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Hongtao Liu
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Comprehensive Cancer Center
Locations
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2014-02469
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB14-0709
Identifier Type: OTHER
Identifier Source: secondary_id
IRB14-0709
Identifier Type: -
Identifier Source: org_study_id
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