Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies

NCT03272633 | Terminated Early Phase 1 Results DMC FDA Drug

• 4 other identifiers: 011702NCI-2017-01537Pro20170000537P30CA072720
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to decrease in size and may help control cancer in patients receiving a stem cell transplant.

Conditions

Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia in Remission; Hematopoietic Cell Transplantation Recipient; JAK2 Gene Mutation; Loss of Chromosome 17p; Mantle Cell Lymphoma; Minimal Residual Disease; Myelodysplastic Syndrome; Non-Hodgkin Lymphoma; Plasma Cell Myeloma; RAS Family Gene Mutation; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Hematologic Malignancy; Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Therapy-Related Acute Myeloid Leukemia; Therapy-Related Myelodysplastic Syndrome; TP53 Gene Mutation

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Up to 8 weeks after last protocol treatment

• the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu

  Up to 12 weeks of completion of therapy

Secondary Outcomes (1)

• Induction of Host T Cells Reactive With Tumor Associated Epitopes

  Up to 8 weeks after last protocol treatment

Study Arms (2)

Cohort I (initial IHC within 42 days)

EXPERIMENTAL

Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Biological: Irradiated Allogeneic Cells

Cohort II (initial IHC within 70 days or after relapse)

EXPERIMENTAL

Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Biological: Irradiated Allogeneic Cells

Interventions

Allogeneic Hematopoietic Stem Cell Transplantation PROCEDURE

Receive IHC

Also known as: Allogeneic Hematopoietic Cell Transplantation, allogeneic stem cell transplantation, HSC, HSCT

Cohort I (initial IHC within 42 days); Cohort II (initial IHC within 70 days or after relapse)

Irradiated Allogeneic Cells BIOLOGICAL

Correlative studies

Cohort I (initial IHC within 42 days); Cohort II (initial IHC within 70 days or after relapse)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with disease (stage) eligible per cohort
• COHORT 1: patients undergoing high dose chemotherapy with autologous stem cell rescue and ?high-risk? disease as defined below:
• Diffuse large cell lymphoma or peripheral T cell lymphoma (including specified World Health Organization \[WHO\] subtypes) not in computed tomography (CT)-positron emission tomography (PET) complete remission at time of high dose therapy
• Diffuse large cell lymphoma with ?double hit? or ?double expressor? features
• Diffuse large cell lymphoma or peripheral T cell lymphoma (including WHO specified subtypes) refractory to standard induction therapy OR relapsing within 1 year of treatment OR in greater that second complete remission (CR)
• Mantle cell lymphoma not in CR1
• Multiple myeloma with ONE (or more) of the following high risk features:
• Less than very good partial remission at time of high dose therapy
• High Revised-International Staging System (R-ISS) (stage III ? 2 microglobulin \>= 5.5 plus lactate dehydrogenase \[LDH\] \> upper limit of normal \[ULN\] and/or del17p, t(4;14), t(14;16)) at time of diagnosis
• Cytogenetics or fluorescent in situ hybridization (FISH) del17p
• COHORT 2: patients with high risk disease having undergone an allogeneic hematopoietic stem cell transplant from a 10/10 human leukocyte antigen (HLA) matched donor with one of the following disease subtypes:
• Acute myeloid leukemia (AML) in CR1 with high risk features (European Leukemia Network \[ELN\]) at presentation
• Diagnostic sample with either t(6;9), t(9;22), 11q23, inv 3, -5, -7, del17p, complex cytogenetics, NPMwt-flt3ITD+, OR p53 mutation (mut); patients whose samples have mutations in RUNX1 or ASXL1 are also eligible (unless the patient has favorable cytogenetics)
• AML in CR1 with measurable minimal residual disease (MRD) by molecular (e.g., myeloid mutation profile, polymerase chain reaction \[PCR\] for NPM1, core-binding factor \[CBF\], mixed lineage leukemia \[MLL\]) or flow cytometry
• AML not in CR1 (including patients with morphologic CR but with incomplete recovery, CRi)

You may not qualify if:

• Non-English speaking person
• Patients undergoing haploidentical allogeneic hematopoietic stem cell transplants are not eligible; patients undergoing \< 10/10 HLA allele matched allogeneic transplant are not eligible
• Pregnant women
• DONOR: Non-English speaking person
• DONOR: Pregnant women

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Chromosome 17 deletion; Lymphoma, Mantle-Cell; Neoplasm, Residual; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin; Multiple Myeloma; Lymphoma, Large B-Cell, Diffuse; Hematologic Neoplasms; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Marrow Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoma, B-Cell; Neoplasms by Site

Results Point of Contact

• Title: Roger K. Strair, MD
• Organization: Cancer Institute of New Jersey Rutgers

strairrk@cinj.rutgers.edu

732-235-4523

Study Officials

• Roger Strair

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, RWJMS

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 5, 2017
• Study Start: October 26, 2020
• Primary Completion: June 30, 2022
• Study Completion: September 22, 2022
• Last Updated: June 26, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-06

Locations

US (1)