Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Mycophenolic Acid

Tacrolimus

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Calcineurin Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

CONDITIONING: Patients undergo Total Body Irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.

TRANSPLANTATION: Patients receive DLI on day -6 and undergo cluster of differentiation 34 (CD34+) selected allogeneic HSCT on day 0

GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.

Total Body Irradiation

Donor Lymphocyte Infusion (DLI)

Mycophenolate mofetil

Allogeneic hematopoietic stem cell transplantation

Laboratory biomarker analysis

Neal Flomenberg, MD

Dolores Grosso, DNP, CRNP

The purpose of this research study is to examine the survival of patients undergoing partially matched hematopoietic stem cell transplant (HSCT) on a new type of treatment approach, which has been developed specifically for patients who have evidence of their disease at the time of transplant. In this research study, a way of strengthening the response of the donor cells against the disease has been developed. Patients will undergo one additional day between the two steps of the transplant which may allow their donor's cells to fight the disease more effectively.

This is a phase II study in which patients receive a haploidentical HSCT from a single donor. The period between the donor lymphocyte infusion (DLI) and tolerizing doses of CY has been extended to allow for an increased period of allogeneic response against tumor targets. The outcomes of patients undergoing this extra time period will be compared to historical data to assess efficacy.

Primary Objective:

1) To assess 1 year relapse free survival in patients undergoing hematopoietic stem cell transplant (HSCT) using the Thomas Jefferson University (TJU) 2 step approach with an extra day inserted between the DLI and administration of cyclophosphamide (CY).

Secondary Objectives:

1. To assess the consistency and pace of engraftment.
2. To assess the pace of T cell and B cell immune recovery.
3. To assess regimen related toxicity, (GVHD) graft-versus-host disease incidence and severity, and overall survival in patients undergoing treatment on this protocol. .
4. To assess the tolerance of the period of fever, diarrhea, and rash in each arm in an effort to determine whether a longer interval prior to cytoxan changes this side effect qualitatively compared to prior patient groups or concurrent patient groups. N.B. Patients with hematologic malignancies in remission will continue to be transplanted without modification to the original 2-step approach and will serve as a concurrent comparison group.
5. To collect leukemia samples prior to transplant and after relapse whenever possible. To assess the overall degree of HLA-class I and class II expression on these paired samples. To test for loss of one or both HLA haplotypes in the relapsed tumor specimens.
6. To determine the number of cluster of differentiation 4 (CD4+) cluster of differentiation 25 (CD25+) FOXP3+ regulatory cells post HSCT and to assess whether this is correlated with the development of GVHD after transplant.

Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Human Leukocyte Antigen Partially-Matched Related Donor

To assess relapse free survival in participants undergoing Hematopoietic Stem Cell Transplant (HSCT) using the Thomas Jefferson University 2 step approach with an extra day inserted between the donor lymphocyte infusion (DLI) and administration of cyclophosphamide.

Sidney Kimmel Cancer Center at Thomas Jefferson University

CONDITIONING: Patients undergo TBI BID on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.

TRANSPLANTATION: Patients receive DLI on day -6 and undergo CD34+ selected allogeneic HSCT on day 0

GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.

Total Body Irradiation: Undergo TBI

Donor Lymphocyte Infusion (DLI): Undergo DLI

Cyclophosphamide: Given IV

Tacrolimus: Given IV or PO

Mycophenolate mofetil: Given IV or PO

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

Laboratory biomarker analysis: Correlative studies

Allogeneic HSCT

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Neal Flomenberg

Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT)

Pace of T-cell and B-cell Immune Recovery

CONDITIONING: Patients undergo Total Body Irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.

TRANSPLANTATION: Patients receive DLI on day -6 and undergo cluster of differentiation 34 (CD34+) selected allogeneic HSCT on day 0

GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.

Total Body Irradiation: Undergo TBI

Donor Lymphocyte Infusion (DLI): Undergo DLI

Cyclophosphamide: Given IV

Tacrolimus: Given IV or PO

Mycophenolate mofetil: Given IV or PO

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

Laboratory biomarker analysis: Correlative studies

Regimen Related Toxicities Graded According to the National Cancer Institute (NCI) Common Toxicity Criteria, Version 3.0

CONDITIONING: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.

TRANSPLANTATION: Patients receive DLI on day -6 and undergo cluster of differentiation (CD34+) selected allogeneic HSCT on day 0

Graft-versus-host disease (GVHD) PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.

Total Body Irradiation: Undergo TBI

Donor Lymphocyte Infusion (DLI): Undergo DLI

Cyclophosphamide: Given IV

Tacrolimus: Given IV or PO

Mycophenolate mofetil: Given IV or PO

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

Laboratory biomarker analysis: Correlative studies

Incidence and Severity of GVHD, Graded According to Standard Criteria

CONDITIONING: Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.

TRANSPLANTATION: Patients receive Donor Lymphocyte Infusion (DLI) on day -6 and undergo cluster of differentiation (CD34+) selected allogeneic HSCT on day 0

Graft-versus-host disease (GVHD) PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.

Total Body Irradiation: Undergo TBI

Donor Lymphocyte Infusion (DLI): Undergo DLI

Cyclophosphamide: Given IV

Tacrolimus: Given IV or PO

Mycophenolate mofetil: Given IV or PO

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

Laboratory biomarker analysis: Correlative studies

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies	NCT01341301	Hematologic Mal...	Total Body Irra... Donor Lymphocyt... Cyclophosphamid... Tacrolimus Mycophenolate m... Allogeneic hema... Laboratory biom...	18 Years -	Thomas Jefferson University
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies	NCT01341301	Hematologic Mal...	Total Body Irra... Donor Lymphocyt... Cyclophosphamid... Tacrolimus Mycophenolate m... Allogeneic hema... Laboratory biom...	18 Years -	Thomas Jefferson University
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies	NCT01341301	Hematologic Mal...	Total Body Irra... Donor Lymphocyt... Cyclophosphamid... Tacrolimus Mycophenolate m... Allogeneic hema... Laboratory biom...	18 Years -	Thomas Jefferson University

Spots Global Cancer Trial Database for tju 2 step

Every month we try and update this database with for tju 2 step cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tju 2 step

Every month we try and update this database with for tju 2 step cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tju 2 step cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.