• Return to search results
• Start new search

Investigator(s):
Alan Wayne, M.D. Principal Investigator Phone: 301-496-4256 waynea@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

---

Primary Eligibility:

Patient

• Age: 5 to 21
• Hodgkin’s lymphoma or NHL, AML, ALL, acute hybrid leukemia, MDS, CML and JMML
• No active CNS malignancy
• Performance status 0-2
• Life expectancy > 3 months
• Adequate liver, renal, pulmonary, left ventricular function
• No HIV infection or active hepatitis B or C
• No pregnant or nursing females
• No Fanconi anemia in MDS patients

Donor

• Donor must be 5 or 6 antigen HLA-matched first-degree related donor
• Weight ≥ 15 kg
• Adequate venous access for peripheral apheresis or consent to use central venous catheter for apheresis
• No history of medical illnesses posing prohibitive risks to donation
• No anemia or thrombocytopenia
• No pregnant or nursing females
• No HIV infection or seropositive hepatitis B or C

---

Treatment Plan:

Induction:

• Patients with lymphoma receive fludarabine IV over 30 minutes on days 1-3 and etoposide, doxorubicin, and vincristine IV over 24 hours daily on days 1-4
• Patients also receive cyclophosphamide IV over 30 minutes on day 5, oral prednisone 2-4 times daily on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 6 and continuing until blood counts recover
• Patients with leukemia or MDS receive fludarabine IV over 30 minutes and cytarabine IV over 4 hours on days 1-5; patients also receive G-CSF SC once daily beginning on day 0 and continuing until blood counts recover
• Treatment repeats every 21 days for up to 3 courses until the target absolute CD4 count is achieved

Preparative regimen:

• On day 22 after the final course of induction chemotherapy, patients receive fludarabine IV over 30 minutes, cyclophosphamide IV over 2 hours daily for 4 days

Transplantation:

• Allogeneic PBSCs are infused on day 0; patients receive G-CSF SC daily beginning on day 0 until blood counts recover

Graft-versus-host disease (GVHD) prophylaxis:

• Patients receive cyclosporine IV over 2 hours twice daily beginning on day -1 and, once oral medications are tolerated, continuing orally twice daily until day 100 followed by a taper until day 180
• Patients with progressive disease on day 28 post-transplantation may undergo donor lymphocyte infusions (DLI); immunosuppression is withdrawn and patients receive nonmobilized DLI IV every 2-4 weeks in the presence of progressive disease and the absence of GVHD
• Patients are followed weekly for 1 month, at days 60, 100, 180, and 365, every 6 months for 1 year, and then annually for at least 3 years

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/11/08
Updated: 1/5/09