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CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)

CD8 Depleted Donor Lymphocyte

Richard Champlin, MD, BS

Primary Objectives:

To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD).

Secondary Objectives:

* To evaluate safety and treatment related mortality after CD8 depleted DLI.
* To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.
* To evaluate the incidence and timing of pancytopenia following DLI.
* To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM).
* To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions.
* To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.

CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation

CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation

Eligix

M.D. Anderson Cancer Center

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Blinatumomab

Blinatumomab+Haplo-Mismatched Cell Therapy (HMCT)

Blinatumomab per package insert - via continuous infusion days 1-28 of Cycle 1 and Cycle 2, every 42 days.

HMCT infusion Cycle 1, Day 15 and Cycle 2, Day 8 \& Day 15

Haplo-Mismatched Cell Therapy (HMCT)

Noah Merin, MD PhD

Single center Phase 1 dose escalation trial of the combination of standard-of-care blinatumomab plus Haplo-Mismatched Cellular Therapy (HMCT). HMCT refers to the infusion of donor peripheral blood mononuclear cells collected via pheresis from a haploidentical family member - the procedure is analogous to giving a donor lymphocyte infusion outside of the setting of an allogeneic stem cell transplant; also known as 'microtransplantation'. The HMCT is an unselected mix of lymphocytes and leukocytes, but the product dose escalation will be done based on the T cell content.

Ten recipients are planned. Each subject will be administered one infusion of HMCT during the first cycle of blinatumomab and two infusions during cycle two of blinatumomab; the CD3+ cell dose of the HMCT infusion is governed by dose escalation / de-escalation following a Bayesian method.

This single center, phase 1 study will examine the safety, side effects, and effectiveness of combining the investigational use of Haplo-Mismatched Cellular Therapy (HMCT) in combination with blinatumomab. Investigators plan to give HMCT starting on day 15, after the initial CRS caused by blinatumomab has resolved. The investigational treatment will start with 1% of the typical HMCT dose (10e6 CD3+ cells/kg) and will employ a modified dose escalation design as an additional safety measure. The primary end points will be DLT of the combination of blinatumomab and HMCT.

Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL

IIT2017-05-MERIN-BLINHMCT: Blinatumomab Plus HLA-Mismatched Cellular Therapy (HMCT) for Relapsed/Refractory CD19+ ALL

Number of Dose Limiting Toxicities experienced by patients undergoing HLA mismatched cellular therapy (HMCT) of allogenic CD3+ cells in combination with blinatumomab.

Bone marrow aspiration and local peripheral blood counts will be used to measure response. CR is defined as the following:

* Less than or equal to 5% blasts in the bone marrow
* No evidence of disease, AND
* Full recovery of peripheral blood counts: platelets \> 100,000/ul, and ANC \> 1000/ul

Bone marrow aspiration and local peripheral blood counts will be used to measure response. CRh is defined as the following:

* Less than or equal to 5% blasts in the bone marrow
* No evidence of disease, AND
* Full recovery of peripheral blood counts: platelets \> 50,000/ul, and ANC \> 500/ul

Bone marrow aspiration and local peripheral blood counts will be used to measure response. CRi is defined as the following:

* Less than or equal to 5% blasts in the bone marrow
* No evidence of disease, AND
* Full recovery of peripheral blood counts: platelets \> 100,000/ul, and ANC \> 1000/ul

Bone marrow aspiration and local peripheral blood counts will be used to measure response. Blast-free hypoplastic or aplastic bone marrow response is defined as the following:

* Less than or equal to 5% blasts in the bone marrow
* No evidence of disease, AND
* Full recovery of peripheral blood counts: platelets \> 50,000/ul, and ANC \> 500/ul

MRD remission is defined as the occurrence of an MRD level below 10\^-4 measured by quantitative reverse transcription polymerase chain reaction (PCR) or flow cytometry.

Complete response defined as: no detectable leukemic cells by PCR or flow cytometry.

Amgen

Cedars-Sinai Medical Center

Assistant Clinical Professor, Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation	NCT00038818	Chronic Myeloge... Multiple Myelom... Non Hodgkin's L... Hodgkin's Disea... Chronic Lymphoc...	CD8 Depleted Do...	-	M.D. Anderson Cancer Center
Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL	NCT03751709	B-Cell Acute Ly... ALL, Adult B-ALL	Blinatumomab Haplo-Mismatche...	18 Years -	Cedars-Sinai Medical Center

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