Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Antimetabolites

Enzyme Inhibitors

1. Pre-DLI Salvage Chemotherapy (at the discretion of the treating physician)
2. DLI will be administered 2 +/- 1 weeks after pre-DLI chemotherapy. The minimum CD3+ cell counts in DLI product should be 1 x 107 cells/kg for sibling and \~1 x 106/kg for match unrelated donors based on recipient weight
3. No Azacitidine will be given

1. Pre-DLI Salvage Chemotherapy (at the discretion of the treating physician)
2. DLI will be administered 2 +/- 1 weeks after pre-DLI chemotherapy. The minimum CD3+ cell counts in DLI product should be 1 x 107 cells/kg for sibling and \~1 x 106/kg for match unrelated donors based on recipient weight
3. Azacitidine 45 mg/m2 IV on Days 4, 6, 8, and 10 post-DLI.

1. Pre-DLI Salvage Chemotherapy (at the discretion of the treating physician)
2. DLI will be administered 2 +/- 1 weeks after pre-DLI chemotherapy. The minimum CD3+ cell counts in DLI product should be 1 x 107 cells/kg for sibling and \~1 x 106/kg for match unrelated donors based on recipient weight
3. Azacitidine 75 mg/m2 IV on Days 4, 6, 8, and 10 post-DLI.

At the discretion of the treating physician

Pre-DLI Salvage Chemotherapy

Donor Leukocyte Infusion (DLI)

Peter Westervelt, M.D., Ph.D.

This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while maintaining the anticancer effects.

PRIMARY OBJECTIVES:

-To determine the Maximum Tolerated Dose (MTD) of 5-AzaC (azacitidine) when given after chemotherapy and DLI in patients with AML/MDS who relapse after allogeneic stem cell transplant.

SECONDARY OBJECTIVES:

* To determine the rate of Grades II-IV and III-IV acute GVHD (aGVHD) in first 100 days after DLI.
* To determine the rates of complete remission (CR), partial remission, (PR) and complete remission with incomplete count recovery (CRi), and overall response rate (CR+ CRi + PR).
* To determine overall survival 100 days after DLI.
* To determine the effects of increasing dose of 5-AzaC on frequency and absolute number of resting regulatory T-cells (rTregs) and activated Tregs (aTregs) at baseline, 7 days, 14 days, 21 days, and \~60 days after first dose of 5-AzaC.

Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant

A Phase I Study of the Safety and Feasibility of Azacitidine After Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome After Allogeneic Stem Cell Transplantation

MTD is defined as the maximum dose level immediately below the dose level at which 2 patients of a cohort (3 to 6 patients) experience dose-limiting toxicity during the first cycle.

National Cancer Institute (NCI)

Washington University School of Medicine

Vaccines

Immunomodulating Agents

AML cell vaccine and Donor Leukocyte Infusion (1x107/kg)

AML cell vaccine and Donor Leukocyte Infusion (1x108/kg)

AML cell vaccine alone. x4 doses 3 weeks apart

RFUSIN2-AML1

Donor leukocyte infusion (DLI)

AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose

RFUSIN2-AML1 and donor leukocyte infusion

AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose

Ghulam J Mufti

Wendy Ingram

The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine' in patients with poor prognosis acute myeloid leukaemia (AML).

Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2

A Phase I Study of Lentivirus Transduced Acute Myeloid Leukaemic Cells (AML) Expressing B7.1 (CD80) and IL-2 for the Potential Enhancement of Graft Versus Leukaemia(GvL) Effect in Poor Prognosis AML

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant	NCT01390311	Leukemia, Myelo... Myelodysplastic...	Azacitidine Pre-DLI Salvage... Donor Leukocyte...	18 Years -	Washington University School of Medicine
Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant	NCT01390311	Leukemia, Myelo... Myelodysplastic...	Azacitidine Pre-DLI Salvage... Donor Leukocyte...	18 Years -	Washington University School of Medicine
Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2	NCT00718250	Leukemia, Myelo...	RFUSIN2-AML1 Donor leukocyte... RFUSIN2-AML1 an... RFUSIN2-AML1 an...	18 Years -	King's College Hospital NHS Trust
Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2	NCT00718250	Leukemia, Myelo...	RFUSIN2-AML1 Donor leukocyte... RFUSIN2-AML1 an... RFUSIN2-AML1 an...	18 Years -	King's College Hospital NHS Trust

Spots Global Cancer Trial Database for donor leukocyte infusion (dli)