Trials / Suspended
SuspendedNCT02333162
Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant
A Phase I Study of Intensity Modulated Total Marrow Irradiation (IMTMI) in Addition to Fludarabine/Melphalan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
- Status
- Suspended
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects and the best dose of intensity modulated total marrow irradiation (IMTMI) when given together with fludarabine phosphate and melphalan in treating patients with cancers of the blood (hematologic) that have returned after a period of improvement (relapsed) undergoing a second donor stem cell transplant. IMTMI is a type of radiation therapy to the bone marrow that may be less toxic and may also reduce the chances of cancer to return. Giving fludarabine phosphate, melphalan, and IMTMI before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also 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.
Detailed description
PRIMARY OBJECTIVES: 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
- Previously Treated Myelodysplastic Syndrome
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Hematologic Malignancy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine Phosphate | Given IV |
| DRUG | Melphalan | Given IV |
| RADIATION | Intensity-Modulated Radiation Therapy | Undergo IMTMI |
| RADIATION | Total Marrow Irradiation | Undergo IMTMI |
| PROCEDURE | Allogeneic Hematopoietic Stem Cell Transplantation | Undergo allogeneic PBSCT |
| PROCEDURE | Peripheral Blood Stem Cell Transplantation | Undergo allogeneic PBSCT |
| PROCEDURE | Allogeneic Bone Marrow Transplantation | Undergo allogeneic BMT |
| DRUG | Tacrolimus | Given IV or PO |
| DRUG | Mycophenolate Mofetil | Given IV or PO |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2014-12-05
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2015-01-07
- Last updated
- 2026-03-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02333162. Inclusion in this directory is not an endorsement.