Clinical trial · Interventional
Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies
UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
NCT00714259CI-TRIAL-00028748terminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual goals could not be met within a timely manner
Summary
Brief summary (as posted)
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL / SLL | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | ALIAS | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Waldenstroms | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Infusion of Stem Cells | Other | — | UNRESOLVED |
| Total Body Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Non Myeloablative Treatment
- description
- Non-myeloablative Transplant Conditioning Chemotherapy : Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\*6 CD34+ cells per kilogram of recipient weight.
- interventionNames
- Drug: Fludarabine
- Radiation: Total Body Irradiation
- Other: Infusion of Stem Cells
Primary outcomes (4)
- measure
- Progressive Free Survival Post Transplant
- timeFrame
- 100 days post transplant
- description
- subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Stage II or III non-progressive disease Multiple Myeloma. * CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease. * ≤ 70 years old. * Eligible and willing HLA matched related donor. * Bilirubin \<2xULN. * ALT and AST \<3xULN. * LVEF \> 40%. * Creatinine Clearance \>40mL/min. * Pulmonary function DLCO corrected to ≥ 70%. * Minimum performance score of 70%. * Platelet count \>130 x103 micro L. * LDH ≤1.5xULN. * No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity. * No uncontrolled infections. Exclusion Criteria: * Age \>70 years old. * Performance status \<70%. * Uncontrolled infections or is HIV positive * Prior malignancies that are felt to have a \<80% probability of being cured. * Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant. * Prior Allograft * History of rapidly growing disease at diagnosis or at any progression or have MDS. * No eligible and willing HLA matched donor.
References
Publications (0)
Data not yet available
No reference posted for this study.