Phase 2
N=16
Allogeneic Transplantation From Related Haploidentical Donors
Blood Cancer · Leukemia · Graft Versus Host Disease · Malignancy · CLL
Bottom Line
View on ClinicalTrials.gov: NCT00185692 ↗Enrolled (actual)
16
Serious AEs
87.5%
Results posted
Jan 2017
Primary outcome: Primary: Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- non-myeloablative hematopoietic cell transplantation (Procedure); Anti-Thymocyte Globulin (Drug); Cyclosporine (Drug); Mycophenolate Mofetil (Drug); G-CSF (Drug); Solumedrol (Drug); Acetaminophen (Drug); Diphenydramine (Drug); Hydrocortisone (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning |
4 | — |
| SECONDARY Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant |
1 | — |
Summary
The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+ selected hematopoietic cells from a haploidentical related donor following a nonmyeloablative regimen of total lymphoid irradiation (TLI) and antithymocyte globulin (ATG).
Eligibility Criteria
Inclusion Criteria
- Age ≥ 50 years with hematologic malignancies treatable by a mixed chimera allogeneic HCT.
- For patients ≤ 50 years of age with hematologic malignacies treatable with mixed chimera HCT who because of pre-exisiting medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional transplants.
- Indolent advanced stage NHL, CLL, HD - Must have received and failed front-line therapy.
- Multiple myeloma (Stage II or III) - Must have received prior chemotherapy. Consolidation after prior autografting is permitted.
- AML/ALL - Must be in complete hematologic remission and have received cytotoxic chemotherapy at some stage before transplant. Patients with molecular or cytogenetic relapse will be accepted providing a donor is available. Patients with persistent or refractory disease will be considered on a case by case basis and transplants must be approved by the principal investigator.
- CML - Patients will be accepted in chronic or accelerated phase. Patients who have received prior autografts after high dose therapy or have undergone intensive chemotherapy for either peripheral blood stem cell mobilization or treatment of advanced CML may be enrolled provided they are in CR, chronic phase or accelerated phase.
- MDS - All patients with MDS will be eligible for this protocol, however, those patients with >10% blasts will require chemotherapy to reduce the blast % to 4 mg/dl and/or transaminases > 3x the upper limit of normal. If hyperbilirubinemai is due to a known cause that will not increase the risks of transplant, than this upper limit may be exceeded.
- Renal: creatinine clearance < 50 cc/min (24 hour urine collection)
- Karnofsky performance score < 60%
- Patients with poorly controlled hypertension.
- Documented fungal disease that persists despite treatment
- HIV positive patients.
- Hepatitis B and C positive patients will be evaluated on a case by case basis
- Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or principal investigator would place the patient at unacceptable risk from this regimen.
Data sourced from ClinicalTrials.gov (NCT00185692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.