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Monoclonal Antibodies

Tocilizumab for Blood Cancer Post-Transplant Care

Phase 2

Waitlist Available

Led By Koen van Besien, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have a confirmed diagnosis of one of the following: Relapsed or refractory acute leukemia (myeloid or lymphoid), Acute leukemia in first remission at high-risk for recurrence, Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis, Myelodysplastic syndromes, Chronic myeloproliferative disease, Recurrent, refractory or high-risk malignant lymphoma, Chronic lymphocytic leukemia, relapsed or with poor prognostic features, Multiple myeloma, Other hematological disorder in need of allogeneic transplant (e.g. blastoid dendritic cell neoplasm), Age ≥ 18 years, Likely to benefit from allogeneic transplant in the opinion of the transplant physician, An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame, Karnofsky Performance Status (KPS) of ≥ 70%, Acceptable organ function as defined below: Serum bilirubin: <2.0 mg/dL, ALT (SGPT) <3x upper limit of normal (ULN), Creatinine Clearance: >50 mL/min/1.73m2 (eGFR as estimated by the modified MDRD equation), Left ventricular ejection fraction >40%, Pulmonary diffusion capacity >40% predicted, Ability to understand and the willingness to sign a written informed consent document

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post-transplant

Awards & highlights

Study Summary

This trial is testing whether ATG can be replaced with tocilizumab in the haplo-cord transplant conditioning regimen to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease.

Who is the study for?

Adults with certain blood cancers or disorders needing a bone marrow transplant, who can't find a matching donor quickly. They should be in relatively good health with decent organ function and no severe allergies to tocilizumab or similar drugs. Pregnant women, those with uncontrolled infections, HIV, or serious liver issues are excluded.Check my eligibility

What is being tested?

The trial is testing if replacing anti-thymocyte globulin (ATG) with tocilizumab in the pre-transplant treatment regimen can improve immune recovery and reduce relapse while maintaining low graft failure and GVHD rates. It includes Fludarabine, Total Body Irradiation, Melphalan as part of the conditioning.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medication components like tocilizumab; complications related to bone marrow suppression such as infection risk; organ inflammation due to Tocilizumab; and general symptoms from radiation or chemotherapy like fatigue and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment

Secondary outcome measures

Overall Survival

Progression-Free Survival

Proportion of Acute Graft-versus-Host Disease

+4 more

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

Inpatient admission

fatigue

agranulocytosis

100%

80%

60%

40%

20%

Study treatment Arm

Tocilizumab

Placebo

Trial Design

4Treatment groups

Experimental Treatment

Group I: ATG Group IVExperimental Treatment4 Interventions

Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old) Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen. Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen. Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.

Group II: ATG Group IIIExperimental Treatment5 Interventions

Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5 of the transplant conditioning regimen. Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old) Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen. Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen. Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.

Group III: ATG Group IIExperimental Treatment5 Interventions

Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen. Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old) Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen. Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen. Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.

Group IV: ATG Group IExperimental Treatment5 Interventions

Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen. Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old) Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen. Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen. Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

FDA approved

Tocilizumab

FDA approved

Antithymocyte immunoglobulin (rabbit)

FDA approved

Total Body Irradiation

2006

Completed Phase 3

~820

Melphalan

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,507 Total Patients Enrolled

Koen van Besien, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University

6 Previous Clinical Trials

337 Total Patients Enrolled

Alexandra Gomez Arteaga, MDPrincipal InvestigatorWeill Medical College of Cornell University

2 Previous Clinical Trials

316 Total Patients Enrolled

Media Library

Tocilizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04395222 — Phase 2

Blood Cancers Research Study Groups: ATG Group III, ATG Group IV, ATG Group I, ATG Group II

Blood Cancers Clinical Trial 2023: Tocilizumab Highlights & Side Effects. Trial Name: NCT04395222 — Phase 2

Tocilizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04395222 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration still open for this trial?

"The clinicaltrials.gov website verifies that this medical investigation, which was posted on October 7th 2020, is currently hunting for participants. It has been modified recently, with the last change made on September 20th 2022."

Answered by AI

What is the limit of subjects enrolled in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial is actively recruiting, with the initial posting on October 7th 2020 and its most recent update occurring on September 20th 2022. 70 participants are needed from a single site for this study to be successful."

Answered by AI

Has the FDA given Tocilizumab its stamp of approval?

"Given its Phase 2 status, meaning that there is safety data but not efficacy information, our group at Power assigned Tocilizumab a score of 2 on the 1-3 scale."

Answered by AI