Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

The amount of cells received：1.0-5.0×10\^6 CAR+T cells/kg

CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)

C-CAR011

Xiaojun Huang

This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT

A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10\^6CAR+T cells/kg

C-CAR011 Treatment in Subjects With ALL After HSCT

A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）

Overall survival (OS) after C-CAR011 infusion

Progression free survival（PFS）after C-CAR011 infusion

Cellular Biomedicine Group Ltd.

Peking University People's Hospital

Chair

Symptoms and General Pathology

Syndrome

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hodgkin Disease

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Hodgkin Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Mycophenolic Acid

Tacrolimus

Busulfan

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Calcineurin Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.

30 mg/m\^2 IV daily on Day -6 through Day -2.

1 mg/kg PO OR 0.8 mg/kg IV four times daily on Day -6 through Day -3.

15 mg/kg PO three times daily (max daily dose of 3g) starting on Day +5.

Mycophenolate Mofetil

Dosed based on drug levels; begin on Day +5 at 1 mg IV daily.

Yvette Kasamon, M.D.

This research is being done to learn more about reduced-intensity bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative.

The main goal of the study is to determine how quickly the donor's bone marrow "takes" in your body. Other goals include describing how many people accept the bone marrow and how quickly the blood counts come up; describing Graft-versus-host disease (GVHD) and other complications; and describing how many people survive without progressive cancer and survive overall

At the present time there are few or no cures for people with cancer of the blood or lymph glands outside of a bone marrow transplant (BMT). BMT has developed over several decades of research as an effective treatment of various malignant and nonmalignant hematologic diseases.

This research is being done to learn more about reduced-intensity bone marrow transplantation (BMT), also known as a "mini" transplant for patients with blood cancers, using bone marrow from a relative. The bone marrow for this transplant comes from a relative who is a half-match or "haplo" match to you. Possible donors include parents, siblings, and children.

"Mini" transplants have been given to many people with various cancers but are considered experimental. Over 200 people at Johns Hopkins have received mini transplants with high doses of cyclophosphamide after the transplant. However, the chemotherapy combination and other treatment given before those transplants were different from what is in this study. Although all of the chemotherapy and immune-lowering drugs used in this study are approved by the Food and Drug Administration (FDA), the combination of medications used in this study are not FDA approved and are experimental.

Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers

Reduced-intensity, Related-donor Allogeneic BMT With Fludarabine, Busulfan, and High-dose Posttransplantation Cyclophosphamide for Hematologic Malignancies

Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.

Percentage of participants achieving full-donor chimerism in CD3+ sorted peripheral blood

Percentage of participants alive without disease relapse or progression.

Percentage of participants experiencing disease relapse or progression

Percentage of participants who died due to BMT-related reasons

Percentage of participants experiencing acute and chronic GVHD. Acute GVHD is graded by Przepiorka criteria. Chronic GVHD is graded by NIH consensus criteria and Seattle criteria.

Percentage of participants who failed to engraft.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.

Transplant

Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,: Fludarabine 30 mg/m2 IV once a day for 4 days Busulfan 0.8 mg/kg IV every 12 hours for 4 days Cyclophosphamide 50 mg/kg IV daily for 2 days

BMT Allogenic Transplantation

Age, Continuous

Age, Categorical

Female

Male

Sex/Gender, Customized

United States

Region of Enrollment

Yvette Kasamon

The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
C-CAR011 Treatment in Subjects With ALL After HSCT	NCT03327285	Acute Lymphobla...	C-CAR011	15 Years - 65 Years	Peking University People's Hospital
Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers	NCT01135329	Lymphoma Leukemia Myelodysplastic...	Fludarabine Busulfan Cyclophosphamid... Mycophenolate M... Tacrolimus	6 Months - 75 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers	NCT01135329	Lymphoma Leukemia Myelodysplastic...	Fludarabine Busulfan Cyclophosphamid... Mycophenolate M... Tacrolimus	6 Months - 75 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for acute lymphoblastic leukemia(all)