Clinical trial · Interventional
Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte globulin may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus biological therapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Fludarabine (30mg/m2/day x 5 days on days -9 to -5), cyclophosphamide (2gm/m2/day on day -5), antithymocyte globulin (10mg/kg/day x 4 days on days -5 to -2), tacrolimus (.03 mg/kg/day IVPB continuous infusion), mycophenolate mofetil (1mg PO BID, days +1 to +60), allogenic peripheral blood stem cells
- interventionNames
- Biological: anti-thymocyte globulin
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy for which there is no standard curative therapy, including, but not limited to: Low grade non-Hodgkin's lymphoma (NHL) Mantle cell lymphoma Chronic lymphocytic leukemia (stage II-IV) Myelodysplastic syndrome, including: Refractory anemia (RA) with ringed sideroblasts RA with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Multiple myeloma OR Histologically proven hematologic malignancy that has failed 1 prior therapy OR is at high risk for relapse, including, but not limited to: Intermediate grade NHL High grade NHL Hodgkin's disease Acute lymphoblastic lymphoma Acute myelogenous leukemia OR Histologically proven chronic myelogenous leukemia in chronic or accelerated phase, with the following risk factors that preclude eligibility for standard allogeneic peripheral blood stem cell transplantation: Older age Poor performance status Healthy, partially related HLA 5/6 or 6/6 serologic match donor available A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 to 60 or physiologic 70 Performance status: Karnofsky 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL SGOT and SGPT less than 2 times normal No active hepatitis Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: Ejection fraction greater than 45% OR Cardiac clearance Pulmonary: DLCO at least 50% predicted Other: No active infection HIV-1, HIV-2, and HTLV-1 negative Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
References
Publications (0)
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