Clinical trial · Interventional
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
- 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)
New conditioning regimens are still needed to maximize efficacy and limit treatment-related deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Aplastic Anemia | — | UNRESOLVED | — |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphocytic Leukemia | Lymphoid Leukemia | ALIAS | 0.90 |
| Malignant Lymphoma | Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
| Myeloproliferative Disorder |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG | Drug | — | UNRESOLVED |
| fludarabine/busulfan | Drug | — | UNRESOLVED |
| fludarabine/ melphalan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
- interventionNames
- Drug: fludarabine/busulfan
- Drug: ATG
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
- interventionNames
- Drug: fludarabine/ melphalan
- Drug: ATG
Primary outcomes (1)
- measure
- Number of Participants With Engraftment.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with the following diseases: * Acute myeloid or lymphocytic leukemia in first remission at standard or high-risk for recurrence. * Acute leukemia in greater than or equal to second remission, or with early relapse, or partial remission. * Chronic myelogenous leukemia in accelerated phase or blast-crisis. * Chronic myelogenous leukemia in chronic phase * Recurrent or refractory malignant lymphoma or Hodgkin's disease * Multiple myeloma. * Chronic lymphocytic leukemia, relapsed or with poor prognostic features. * Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features. * Severe aplastic anemia after failure of immunosuppressive therapy. * Age 10-65 years. * Zubrod performance status less than or equal to 2. * Adequate cardiac and pulmonary function. Patients with decreased LVEF \< 40% or DLCO \< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. * Patient or guardian able to sign informed consent. Exclusion Criteria: * Life expectancy is severely limited by concomitant illness. * Serum creatinine greater than 1.5 mg/dL or Creatinine Clearance less than 50 ml/min . * Serum bilirubin greater than or equal to 2.0 mg/dl, SGPT greater than 3 x upper limit of normal * Evidence of chronic active hepatitis or cirrhosis * HIV-positive * Patient is pregnant
References
Publications (0)
Data not yet available