Clinical trial · Interventional
Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant
Phase II Trial of Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Reduced Intensity Allogeneic Stem Cell Transplantation
NCT00143845CI-TRIAL-00026350completedPhase 2Results postedClinicalTrials.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)
The purpose of this study is to determine whether a reduced intensity conditioning regimen for stem cell transplant with donor cells will allow the donor cells to be effective without causing health problems.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Low-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic donor leukocyte infusions | Procedure | — | UNRESOLVED |
| Rapid immunosuppressive taper | Procedure | — | UNRESOLVED |
| Reduced intensity conditioning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunosuppression Taper
- description
- Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
- interventionNames
- Procedure: Reduced intensity conditioning
- Procedure: Rapid immunosuppressive taper
- Procedure: Prophylactic donor leukocyte infusions
Primary outcomes (2)
- measure
- Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grades 2-4
- timeFrame
- 100 days
- description
- The primary objective of this study was to establish the rate of acute GVHD following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies. Glucksberg staging was used for organ grading of GVHD. Clinical GVHD was assessed as follows: Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 rash and no liver or gut involvement Grade 2: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 GI Grade 3: Stage 0-3 skin with Stage 2-3 liver, or Stage 2-4 GI Grade 4: Stage 4 skin rash, or Stage 4 liver involvement
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Patient Inclusion Criteria:
To be eligible a patient MUST meet at least one of the next 4 criteria
* Any patient aged 55 years or older with a hematological malignancy for which allogeneic transplant is considered an appropriate treatment, AND/OR
* Any patient, regardless of age, with a hematologic malignancy for which allogeneic transplant is considered an appropriate treatment and the patient is not eligible for a conventional myeloablative transplant because of organ dysfunction AND/OR
* Any patient, regardless of age, who has relapsed following prior autologous or allogeneic transplant for a hematologic malignancy AND/OR
* Any patient, regardless of age, with one of the following hematological malignancies:
1. Multiple myeloma
1. refractory to or failure following conventional chemotherapy such as VAD (Vincristine, Adriamycin and Dexamethasone), pulse decadron, or alkylating agents, or
2. chromosomal abnormality associated with poor prognosis by cytogenetics or FISH probe.
2. Chronic lymphocytic leukemia patients, Rai stage 3 or 4 and relapsed following/refractory to alkylating agents or nucleoside analog therapy
3. Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or follicular mixed small cleaved and large cell) that is either relapsed or refractory provided the disease is NOT rapidly progressive, NOT bulky, and no mass exceeds 5 cm in greatest dimension.
To be eligible a patient MUST meet all of the following criteria
* In addition to the above criteria ALL patients must meet the following minimum organ function:
1. Cardiac: Ejection fraction at least 30%.
2. Renal: Adequate renal function as defined by creatinine \< 2.0mg OR creatinine clearance \>40 mg/min by 24-hour urine collection or GFR (Glomerular Filtration Rate. (Gender and age-adjusted creatinine clearance \>40ml/min by Gault-Cockroft 55 is acceptable for adults: (140 - age) x weight/72 x Scr \[x 0.85 if female\]).
3. Pulmonary: FEV1 and FVC \>60%.
4. Hepatic: Total bilirubin \<2.0 and AST (Aspartate Aminotransferase)/ALT (Alanine Transaminase) \< 3X institutional normal for age.
5. Performance (adults): Karnofsky score must be at least 60; for pts. under 16, Lansky score must be at least 60.
* Availability of a 5/6 or 6/6 HLA A, B, and DR identical relative who is willing and able to donate allogeneic stem cells. Serological, low resolution or mid resolution molecular typing will determine the degree of match for HLA (Human Leukocyte Antigen) class I regardless of high resolution DNA typing results. High resolution typing will be used to determine the degree of match for HLA-DR.
* No untreated or uncontrolled invasive infections. Patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic and/or culture) that the infection is well controlled. Patients under treatment for infection will be enrolled only after clearance from the Principal Investigator.
* Not pregnant
Patient Exclusion Criteria:
* acute leukemia
* HIV positive patients not eligible
* Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient
* Pregnant
Donor Inclusion Criteria:
* 5/6 or 6/6 HLA match for HLA-A, B, and DR
* Age 3-70 years, good general health
* No contraindication to G-CSF (Granulocyte Colony-Stimulating Factor)stimulation
* No contraindication to leukapheresis of peripheral blood stem cells
* Good general health
Donor Exclusion Criteria:
* HIV positive or history of HIV risk factors
* Presence of other diseases transmissible by blood that pose unacceptable risk to the study subject.
* Pregnant
* Medical or psychological conditions that would make the donor unlikely to tolerate G-CSF - injections or leukapheresisReferences
Publications (0)
Data not yet available
No reference posted for this study.