Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Chromosome 17p Deletion

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide

Nicolaus Kröger, Prof. Dr.

The present study is a multicenter, prospective phase II-study to evaluate the chronic GvHD and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma.

The present study is a multicenter, prospective Phase II-study to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients with multiple myeloma who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related/unrelated and haploidentical donor, and cyclophosphamide as post-transplant GvHD prophylaxis in comparision to a historical group.

In this study will further determine toxicity and safety of cyclophosphamide as GvHD prophylaxis.

All patients will receive on day 3 and 4 after allogeneic stem cell transplan-tation 50 mg/kg BW cyclophosphamide

Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma

Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma. A Phase II Study (Allo-MM-PostCy-Study)

Chronic GvHD at 2 years after allogeneic SCT

Progression-free survival at 2 years after allogeneic SCT

Non-relapsed mortality at 2 years after allogeneic SCT

Incidence of acute GvHD on Day +100 after allogeneic SCT

Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

Toxicity scored according to NCI CTCAE, Version 4.0

Complete remission rate (including sCR and MRD negativity)

Riemser

Clinical Trial Center North (CTC North GmbH & Co. KG)

Universitätsklinikum Hamburg-Eppendorf

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Carcinoma

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Carcinoma, Renal Cell

Anemia

Lymphoma

Hematologic Neoplasms

Anemia, Aplastic

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoma, Follicular

Myeloproliferative Disorders

Neoplasms, Glandular and Epithelial

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Bone Marrow Diseases

Bone Marrow Failure Disorders

Pancytopenia

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Renal Cell Carcinoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Aplastic Anemia

Clear Cell Renal Cell Carcinoma

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Follicular Lymphoma

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Charles A. Linker, M.D.

The primary objective of this study is to examine transplant related mortality (TRM) at 100 days \<30%. A TRM of \>50% is considered unacceptable. This study also seeks a TRM at 12 months that is \<50%, engraftment \>90% (defined as donor cells \>80% at 6 months), and 1 year overall survival \>50%.

Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia

University of California, San Francisco

Fludarabine

Fludarabine phosphate

Immunomodulating Agents

Busulfan

Unrelated Donor Transplant/ Cord Blood Transplant

Reduced Intensity Conditioning, Busulfan and Fludarabine

Mtchell S Cairo, MD

CML, a malignant disorder of stem cells, is characterized by increases in both immature and mature myeloid, erythroid, and lymphoid cells, as well as platelets in the peripheral blood. The cytogenetic hallmark of CML is the Philadelphia(Ph)chromosome found in the malignant cells of 95% of patients. CML comprises 7-20% of all leukemias with an overall incidence in the general population estimated at 1 to 2 per 100,000. The peak incidence occurs in the fifth decade, however, all age groups, including children, are affected. The only reported environmental risk factor is exposure to excessive ionizing radiation that is documented in only a very small percentage of patients. Clinically, CML is characterized by an initial chronic phase in which patients may report mild constitutional symptoms; however, 40-50% are asymptomatic and are diagnosed based upon abnormal blood counts discovered during a routine examination. The chronic phase typically lasts three to five years, and is followed by an accelerated phase distinguished by progressive systemic symptoms, an increasing resistance to conventional chemotherapy, and a rise in the peripheral blood and bone marrow blast count. This evolves rapidly into a blastic crisis characterized by immature cells resembling the blasts characteristic of acute leukemia. The presence of 30% or more blastic cells in the blood or marrow is diagnostic of this final blastic phase which is typically fatal within 3 to 6 months.

The primary treatment options for CML have traditionally been monotherapy with either busulfan or hydroxyurea. Both agents are able to control the clinical symptoms associated with CML, as well as induce hematological remissions in 80% of chronic phase patients. However, complete cytogenetic remissions with either agent are rare, and neither is able to prevent eventual progression to the terminal blastic phase; therefore, these therapies can only be considered palliative.

The primary purpose of this clinical research trial is to study the feasibility of a reduced intensity allogenic transplant for CML. This study will also determine the side effects as well as the response rate.

Further study details will be provided by Columbia University, Division of Pediatric Blood and Marrow Transplantation.

STUDY DESIGN:

Patients less than 30 years of age with CML in 1st or 2nd chronic phase or 1st accelerated phase and a matched related donor, an unrelated cord blood donor, or an unrelated adult donor, will receive 6 days of IV Fludarabine, 4 doses of IV Busulfex, and 5 doses of Alemtuzumab. Patients with persistant RT-PCR positive BCR-Abl and/or Philadelphia chromosome positivity by cytogentics after Day + 100 and a matched related donor would receive DLIx1. If still BCR-Abl or Philadelphia chromosome positive at Day +180 and a matched related donor, patients would receive a second dose of DLI. All patients will receive STI-571 (Gleevec) after hematological reconstitution. Studies for immune reconstitution, chimersim, and MRD will be performed postt AlloSCT.

Reduced Intensity AlloSCT in(CML) With Persistent Disease

A Pilot Study of Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Chronic Myeloid Leukemia (CML) and Adoptive Cellular Immunotherapy Only in Patients With Persistent Disease and Matched Family Donors

Columbia University

Mitchell Cairo, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma	NCT03700450	Multiple Myelom...	Cyclophosphamid...	18 Years - 65 Years	Universitätsklinikum Hamburg-Eppendorf
Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma	NCT03700450	Multiple Myelom...	Cyclophosphamid...	18 Years - 65 Years	Universitätsklinikum Hamburg-Eppendorf
Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia	NCT00513175	Acute Myeloid L... Myelodysplasia Acute Lymphobla... Chronic Lymphoc... Follicular Lymp... Multiple Myelom... NHL Myeloproliferat... Chronic Myeloid... Renal Cell Carc... Aplastic Anemia		16 Years - 75 Years	University of California, San Francisco
Reduced Intensity AlloSCT in(CML) With Persistent Disease	NCT00531310	Chronic Myeloid...	Reduced Intensi...	- 30 Years	Columbia University

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