Neoplasms

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Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

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Leukemia, Lymphoid

Hematologic Neoplasms

Graft vs Host Disease

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

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Immunoproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

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Etoposide phosphate

Thiotepa

Clofarabine

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Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

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Antimetabolites

Remission induction with Clofaranie, Etoposide and Cyclophosphamide combination followed by haplidentical stem cella transplantation if remission achieved.

Clofarabine for remission induction

Etoposide for remission induction

Cyclophosphamide for remission induction

Clofarabine in conditioning before transplantation

Thiotepa in conditioning before transplantation

Melfalan in conditioning before transplantation

Haploidentical transplantation of T-cell depleted graft

Donor lymphocyte infusion

Jacek Toporski, MD, PhD

Despite substantial progress in the treatment pediatric acute leukemia a significant number of children will experience primary or secondary resistance to the treatment. In other words it will be not possible to achieve remission using standard chemotherapy (primary resistance) or the patients will develop chemotherapy resistant relapse (secondary resistance). Children failing to achieve remission or children relapsing after previous allogeneic stem cell transplantation have short life expectancy and palliative treatment still remains the most reasonable option as the escalation of conventional chemotherapy is not longer effective.

The role of Graft versus Leukemia effect was postulated as one of the mechanisms contributing to the leukemia control/eradication after transplantation of hematopoietic stem cells.

In this study the investigators combine intensified multiagent Clofarabine containing chemotherapy with post-induction treatment intensification using reduced intensity conditioning followed by haploidentical hematopoietic stem cell transplantation. Introducing a new drug to the treatment of resistant leukemia the investigators want to achieve a response which allows us to proceed to immediate haploidentical transplantation. Using a haploidentical donor the investigators can avoid time consuming search for an unrelated donor and perform the transplantation at the optimal time-point. Combating therapy resistant leukemia the investigators would like to evoke and utilize potential Graft-versus-Leukemia effect which is much more pronounced in the haploidentical setting, as it is well documented that allogeneic transplantation with a matched donor is not effective in resistant disease. The use of best KIR mismatch donor and post-transplant donor lymphocyte infusion will be implemented in order to develop/intensify graft versus leukemia effect.

Haploidentical Stem Cell Transplantation for Children With Therapy Resistant Leukemia

Clofarabine Based Remission Induction Followed by Haploidentical Stem Cell Transplantation in Children With Refractory Hematological Malignancies

Lund University Hospital

MD, PhD, Head, Section of Pediatric Oncology/Hematology

Symptoms and General Pathology

Acute Disease

Disease Attributes

Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient.

Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.

Double matched sibling transplantation

Moshe Yeshurun, MD

Ron Ram, MD

Patients with active acute leukemia have dismal prognoses even with allogeneic transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse rates are needed.

Relapse risk after double umbilical cord transplantations have been shown to be significantly lower compared to matched sibling and matched unrelated donor transplantations due to better graft versus leukemia effect.

The investigators hypothesize, that concomitant transplantation from 2 matched siblings may improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and other high risk hematological malignancies.

Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies

Rabin Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Haploidentical Stem Cell Transplantation for Children With Therapy Resistant Leukemia	NCT01025778	Acute Lymphobla... Acute Myeloid L...	Clofarabine for... Etoposide for r... Cyclophosphamid... Clofarabine in ... Thiotepa in con... Melfalan in con... Haploidentical ... Donor lymphocyt...	1 Year - 21 Years	Lund University Hospital
Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies	NCT01385072	Relapsed and Re...	Double matched ...	18 Years -	Rabin Medical Center

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