Clinical trial · Interventional
Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Sibling Donors For Treatment Of Patients With High Risk Acute Lymphocytic Leukemia In Complete Remission
NCT00027547CI-TRIAL-00005841completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and donor white blood cells may prevent this from happening. PURPOSE: Phase I/II trial to determine the effectiveness of combination chemotherapy and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia.
Conditions
Conditions (1)
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 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| cyclosporine | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of acute lymphoblastic leukemia (ALL)
* Adult patients must meet 1 of the following criteria:
* Age 50 to 75 with high-risk ALL in complete remission (CR) (less than 5% blasts by morphology on bone marrow aspirate and absence of peripheral blasts) or ALL in second CR (CR2) or greater
* Age 18 to 50 with high-risk ALL in first CR (CR1) and either ineligible for conventional allogeneic transplantation (based on general medical condition) or refused conventional transplantation
* High-risk adult ALL in CR1 includes patients meeting 1 or more of the following criteria:
* Age 30 and over
* Non-T-cell phenotype
* Cytogenetic abnormalities including t(9;22), t(4;11), trisomy 8, or monosomy 7
* Failure to achieve CR after 4 weeks of induction chemotherapy
* Age 18 to 50 with ALL in CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition
* Age 18 to 50 with high-risk ALL in CR2 or greater and refused conventional allogeneic transplantation
* Pediatric patients must meet 1 of the following criteria:
* Under age 18 with high-risk ALL in CR1 and ineligible for conventional allogeneic transplantation based on general medical condition
* High-risk pediatric ALL in CR1 includes patients meeting 1 or more of the following criteria:
* Cytogenetic abnormalities
* t(9;22) with WBC at least 25,000/mm3 at diagnosis
* t(4;11) in patients under age 1 or age 10 and over
* Hypodiploidy (no more than 45 chromosomes)
* Failure to achieve CR after 4 weeks of induction chemotherapy
* Persistent peripheral blasts after 1 week of induction chemotherapy
* Under age 18 with CR2 or greater and ineligible for conventional allogeneic transplantation based on general medical condition
* Age 12 and under allowed if approved by the principle investigator
* No active CNS disease
* Availability of a sibling donor (excluding an identical twin)
* HLA genotypically identical for at least 1 haplotype
* HLA-A, -B, -C, -DRB1, and -DQB1 genotypically or phenotypically identical
PATIENT CHARACTERISTICS:
Age:
* See Disease Characteristics
* 75 and under
Performance status:
* Karnofsky 50-100% (adults)
* Lansky 40-100% (children)
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* No fulminant liver failure
* No alcoholic hepatitis
* No history of bleeding esophageal varices
* No grade II or greater hepatic encephalopathy
* No hepatic synthetic dysfunction evidenced by prolongation of PT with INR greater than 2.5
* No intractable ascites related to portal hypertension
* No bacterial or fungal liver abscess
* No chronic viral hepatitis with bilirubin greater than 5 mg/dL
* No biliary obstruction with bilirubin greater than 5 mg/dL
* No concurrent symptomatic biliary disease
Renal:
* Not specified
Cardiovascular:
* Cardiac ejection fraction at least 30%
Pulmonary:
* No requirement for supplementary continuous oxygen
Other:
* HIV negative
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 1 year after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent posttransplantation growth factors during mycophenolate mofetil administration
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.