Clinical trial · Interventional
Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers
Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- RIST for Heme malignancies
- description
- Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
- interventionNames
- Drug: busulfan
- Drug: cyclosporine
- Drug: fludarabine phosphate
- Drug: mycophenolate mofetil
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Number of Patients With Day 100 Transplant-related Mortality
- timeFrame
- 24 months after day 100 transplant
- description
- Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosed with any of the following:
* Acute myeloid leukemia (AML), meeting 1 of the following criteria:
* Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
* In first complete remission (CR1) with poor-risk cytogenetics, antecedent hematological disease (i.e., myelodysplasia), or treatment-related leukemia
* Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
* Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
* CR1 with Philadelphia chromosome or poor-risk cytogenetics
* Chronic myelogenous leukemia (CML), meeting the following criteria:
* First or second chronic phase
* Must be documented disease progression after imatinib mesylate therapy OR documented lack of cytogenetic response 6 months post-imatinib mesylate initiation OR imatinib mesylate intolerance
* Chronic lymphocytic leukemia (CLL), meeting the following criteria:
* Recurrent disease after fludarabine-based therapy
* Must have chemosensitive disease at the time of relapse, defined as greater than 50% reduction of WBC and lymphadenopathy
* Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease\*), or transformed NHL, meeting 1 of the following criteria:
* Received prior autologous transplantation and cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop
* Relapsed disease that required more than 2 salvage regimens to achieve CR or CRu
* Recurrent multiple myeloma, meeting the following criteria:
* Must have received prior autologous transplantation and demonstrate chemosensitivity at the time of relapse, defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration
* Myelodysplastic syndrome
* Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria:
* Must be transfusion-dependent and have an IPSS score ≥ 1.5, based on WHO criteria
* No RAEB II or del(5q)
* No uncontrolled CNS metastases
* 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor (both patient and donor) available
PATIENT CHARACTERISTICS:
* Karnofsky performance status ≥ 50%
* Serum creatinine ≤ 2 mg/dL
* Not pregnant
* Fertile patients must use effective contraception
* 50 years of age or older
* Patients 18-50 years of age are eligible if meeting 1 of the following criteria:
* Have a preexisting medical condition
* Received prior therapy (i.e., autologous transplantation) and are considered to be too high risk for conventional myeloablative transplantation
* Must be willing to accept or comprehend irreversible sterility as a side effect of therapy
* No uncontrolled active infection
* No psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
* Cardiac ejection fraction ≥ 30%
* Corrected pulmonary-diffusing capacity ≥ 35%
* No serologic evidence of infection with HIV
* No decompensated liver disease with serum bilirubin \> 2.0 mg/dL
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
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