Haplo-identical SCT for High Risk (HR) Hematologic Malignancies w/Post-Transplant In-Vivo T-cell Depletion

• Status: Withdrawn
• Trial end date: 2017-05-11
• Target enrollment: 0
• Participant gender: All

Summary

Although a majority of children with leukemia and most hematological malignancies (Hodgkin's and Non-Hodgkin's lymphomas) can be cured with conventional chemotherapy, a subset of patients with resistant/recurrent high-risk disease are not cured with conventional treatment regimens. Investigators hypothesize that HSCT from a partially matched donor can be safe and effective for patients with very high risk hematologic malignancies when combined with post-transplant cyclophosphamide for prevention of graft-vs-host disease (GVHD).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Treatments: Cyclophosphamide; Fludarabine; Tacrolimus; Thiotepa

Criteria

Inclusion Criteria:

• Patients must have confirmed diagnosis of hematologic malignancy (leukemia, lymphoma or MDS) with the following:

• Resistant/refractory hematologic malignancies (disease exceeding 5% of marrow cells by morphology, which is a description of white blood cell types as assessed via light microscopy; or with measurable extramedullary disease, which is detection of leukemia at sites other than blood and marrow. This includes disease that infiltrates into tissues other than the spleen and marrow. i.e. nodal disease, which is leukemia and/or lymphoma involving a lymph node or chloroma, which is a collection of leukemic cells forming a mass/tumor mass) (Stratum 1).

• Or have relapsed following an initial allogeneic HSCT (Stratum 1).

• And/or lack an adequately matched unrelated donor (URD) or unrelated cord blood (URB) hematopoietic stem cell (HSC) source (see protocol section 2) (Strata 1, 2 & 3).

• Adequate cardiac, pulmonary, renal, and hepatic functions

• Central vascular access providing a combined 3 access ports for all patients.

• Females of childbearing potential must have a negative pregnancy test prior to therapy. Pregnancy tests will only be done prior to therapy. Sexually active patients will be informed of the risk of not using adequate contraception.

• Recipient or legal guardian must be informed of the study, and have signed a consent form.

• Recipients must have a related haplo-identical donor.

Exclusion Criteria:

• High risk hematologic malignancies in remission (and no prior allogeneic HSCT), where allogeneic HSCT is indicated but an appropriately matched HSC source (sibling, unrelated adult or UCB) is available.

• Patients with systemic infections and/or organ dysfunction mandating a reduced intensity conditioning regimen are also excluded.