Allogeneic Transplantation From Related Haploidentical Donors

Not Recruiting

Trial ID: NCT00185692

Purpose

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).

Official Title

Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies

Stanford Investigator(s)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Eligibility


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 < 10%.

   - SAA - Patients with severe aplastic anemia who have failed front line therapy.

   - A fully HLA-identical sibling donor is not available.

   - A matched unrelated donor has not been identified.

   - A haploidentical related donor is available who is in good health and does not have
   contraindications to donation.

Exclusion Criteria:

   - Patients with rapidly progressive intermediate or high grade NHL

   - Uncontrolled CNS involvement with disease

   - Fertile men

   - Women unwilling to use contraceptive techniques during and for 12 months following
   treatment

   - Females who are pregnant

   - Cardiac function: ejection fraction < 30% or cardiac failure requiring therapy

   - Pulmonary: DLCO < 40% predicted and/or receiving supplementary continuous oxygen

   - Liver function abnormalities: elevation of bilirubin 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.

Intervention(s):

procedure: non-myeloablative hematopoietic cell transplantation

drug: Anti-Thymocyte Globulin

drug: Cyclosporine

drug: Mycophenolate Mofetil

drug: G-CSF

drug: Solumedrol

drug: Acetaminophen

drug: Diphenydramine

drug: Hydrocortisone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822

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