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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

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment

Secondary study objectives

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

agranulocytosis

Inpatient admission

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tocilizumab

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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