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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2028-09-30

Brief Summary

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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.

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Detailed Description

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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:

1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)
2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24)
3. Maintenance: DARA IV every 4 weeks (Stop at Day +270)

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Phase 1: 3 dose levels to determine safety. Followed by dose expansion cohort.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional

Phase 1: 3 dose levels to determine safety (15 patients)

Dose expansion:

Daratumumab (DARA) treatment post-HCT

1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)
2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24)
3. Maintenance: DARA IV every 4 weeks (Stop at Day +270)

Group Type OTHER

Daratumumab

Intervention Type DRUG

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:

1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)
2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24)
3. Maintenance: DARA every 4 weeks (Stop at Day +270)

Interventions

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Daratumumab

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:

1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)
2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24)
3. Maintenance: DARA every 4 weeks (Stop at Day +270)

Intervention Type DRUG

Other Intervention Names

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Darzalex®

Eligibility Criteria

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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 (including secondary malignancy)
* 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

Maximum Eligible Age

39 Years