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Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma (ALLO-T-DART)

Primary Purpose

T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Daratumumab
Sponsored by
New York Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-cell Acute Lymphoblastic Leukemia focused on measuring immunotherapy, children, adolescents, young adults

Eligibility Criteria

undefined - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 0-39yrs
  • T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy
  • Planned allogeneic stem cell transplantation with donor identified
  • Performance status ≥ 60%
  • Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
  • Meet organ function requirements
  • Signed IRB approved informed consent

Exclusion Criteria:

  • May not have had a prior autologous or allogenic stem cell transplant
  • May not have uncontrolled, systemic infection at the time of enrollment
  • Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients
  • Must not be pregnant or actively breast feeding
  • Seropositive for HIV, hepatitis B or hepatitis C
  • COPD
  • Asthma
  • Clinically significant cardiac disease

Sites / Locations

  • New York Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interventional

Arm Description

Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: Daratumumab (DARA) treatment post-HCT Induction: DARA IV weekly x 8 doses (Weeks 1-8) Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24) Maintenance: DARA IV every 4 weeks (Stop at Day +270)

Outcomes

Primary Outcome Measures

Patients with dose limiting toxicity (per CTCAE v.5)
occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is probably, or definitely related to daratumumab

Secondary Outcome Measures

Relapse free survival
To measure relapse free survival in patients post HCT and daratumumab

Full Information

First Posted
July 13, 2021
Last Updated
June 29, 2023
Sponsor
New York Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT04972942
Brief Title
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
Acronym
ALLO-T-DART
Official Title
Phase I Trial of Targeted Immunotherapy With Daratumumab Following Myeloablative TBI-Based Conditioning and AlloHCT in Children, Adolescents and Young Adults With High Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (ALLO-T-DART)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.
Detailed Description
Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor. Daratumumab (DARA) treatment post-HCT: Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion cohort (DEC): Further evaluation of PK and PD (correlative studies/exploratory endpoints) to guide future selection of RP2D (15 patients) Treatment Schedule: Induction: DARA IV weekly x 8 doses (Weeks 1-8) Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24) Maintenance: DARA IV every 4 weeks (Stop at Day +270)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-cell Acute Lymphoblastic Leukemia, T-Cell Acute Lymphoblastic Lymphoma
Keywords
immunotherapy, children, adolescents, young adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Phase 1: 3 dose levels to determine safety. Followed by dose expansion cohort.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Other
Arm Description
Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: Daratumumab (DARA) treatment post-HCT Induction: DARA IV weekly x 8 doses (Weeks 1-8) Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24) Maintenance: DARA IV every 4 weeks (Stop at Day +270)
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
Darzalex®
Intervention Description
Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor. Daratumumab (DARA) treatment post-HCT Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: Induction: DARA IV weekly x 8 doses (Weeks 1-8) Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24) Maintenance: DARA every 4 weeks (Stop at Day +270)
Primary Outcome Measure Information:
Title
Patients with dose limiting toxicity (per CTCAE v.5)
Description
occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is probably, or definitely related to daratumumab
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Relapse free survival
Description
To measure relapse free survival in patients post HCT and daratumumab
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 0-39yrs T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy Planned allogeneic stem cell transplantation with donor identified Performance status ≥ 60% Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Meet organ function requirements Signed IRB approved informed consent Exclusion Criteria: May not have had a prior autologous or allogenic stem cell transplant May not have uncontrolled, systemic infection at the time of enrollment Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients Must not be pregnant or actively breast feeding Seropositive for HIV, hepatitis B or hepatitis C COPD Asthma Clinically significant cardiac disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Harrison, RN, MSN
Phone
6172857844
Email
lauren_harrison@nymc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Morris, RN
Phone
7149645359
Email
erin_morris@nymc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Cairo, MD
Organizational Affiliation
New York Medical College
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Troy Quigg, DO
Organizational Affiliation
Helen DeVos Children's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Allyson Flower, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Cairo, MD
Phone
914-594-3650
Email
mitchell_cairo@nymc.edu
First Name & Middle Initial & Last Name & Degree
Lauren Harrison, MSN
Phone
617-285-7844
Email
lauren_harrison@nymc.edu

12. IPD Sharing Statement

Learn more about this trial

Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma

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