Allogeneic HCT With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The present project aims at comparing two nonmyeloablative regimens currently used in 2 major HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from the Seattle group consisting of 2 Gy TBI with fludarabine (90 mg/m²) versus the one from the Stanford group combining 8 Gy TLI with ATG.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital of Liege; University of Liege
• Collaborators: Katholieke Universiteit Leuven; KU Leuven; Maastricht University Medical Center
• Treatments: Fludarabine; Fludarabine phosphate; Thymoglobulin

Criteria

Inclusion Criteria:

PATIENT

1. Diseases

Hematological malignancies confirmed histologically and not rapidly progressing:

• AML in CR (defined as ≤ 5% marrow blasts and absence of blasts in the peripheral blood);

• MDS with ≤ 5% marrow blasts and absence of blasts in the peripheral blood;

• CML in CP;

• MPS not in blast crisis and not with extensive marrow fibrosis,

• ALL in CR;

• Multiple myeloma not rapidly progressing;

• CLL;

• Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);

• Hodgkin's disease with chemosensitive disease.

2. Clinical situations

• Theoretical indication for a standard allo-transplant, but not feasible because:

• Age > 50 yrs;

• Unacceptable end organ performance;

• Patient's refusal.

• Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.

3. Other inclusion criteria

• Male or female; fertile patients must use a reliable contraception method;

• Age < 75 yrs;

• Informed consent given by patient or his/her guardian if of minor age.

DONOR

• Related to the recipient (sibling, parent or child) or unrelated;

• Male or female;

• Any age;

• 10 of 10 (HLA-A, -B, -C, -DRB1, and -DQB1) HLA allele matched;

• Weight > 15 Kg (because of leukapheresis);

• Fulfills criteria for allogeneic PBSC donation according to standard procedures;

• Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.

Exclusion Criteria:

PATIENT

• Any condition not fulfilling inclusion criteria;

• HIV positive;

• Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT.

• Life expectancy severely limited by disease other than malignancy;

• Administration of cytotoxic agent(s) for "cytoreduction" within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);

• CNS involvement with disease refractory to intrathecal chemotherapy.

• Terminal organ failure, except for renal failure (dialysis acceptable)

• Uncontrolled infection;

• Karnofsky Performance Score <70%;

• Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;

• Patient is a female who is pregnant or breastfeeding;

• Previous radiation therapy precluding the use of 2 Gy TBI or 8 Gy TLI;

DONOR

• Any condition not fulfilling inclusion criteria;

• Unable to undergo leukapheresis because of poor vein access or other reasons.