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Tocilizumab for Bone Marrow Transplant

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Weill Cornell Medical College, New York, NYBone Marrow Transplant+1 MoreTocilizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Blood Cancers
  • Bone Marrow Transplant

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Thiotepa
1
Allogeneic HSCT
1
ArmA- Lymphoid

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 5 years post-transplant

1 year post-transplant
Proportion of Acute Graft-versus-Host Disease
21 days post-transplant
Percentage of subjects with successful haplo-derived neutrophil engraftment
Proportion of Failure of the Haplo-Graft
5 years post-transplant
Overall Survival
Progression-Free Survival
Proportion of Chronic Graft-versus-Host Disease
Transplant-Related Mortality
6 months post-transplant
Proportion of Platelet Engraftment Success

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Thiotepa
1
Allogeneic HSCT
2
ArmA- Lymphoid

Side Effects for

Tocilizumab
11%Low ANC
5%fatigue
5%Inpatient admission
5%nausea
5%agranulocytosis
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02034474) in the Tocilizumab ARM group. Side effects include: Low ANC with 11%, fatigue with 5%, Inpatient admission with 5%, nausea with 5%, agranulocytosis with 5%.

Trial Design

4 Treatment Groups

ATG Group III
1 of 4
ATG Group IV
1 of 4
ATG Group I
1 of 4
ATG Group II
1 of 4

Experimental Treatment

70 Total Participants · 4 Treatment Groups

Primary Treatment: Tocilizumab · No Placebo Group · Phase 2

ATG Group IIIExperimental Group · 5 Interventions: Tocilizumab, Fludarabine, Anti-thymocyte globulin (rabbit), Total Body Irradiation, Melphalan · Intervention Types: Drug, Drug, Drug, Radiation, Drug
ATG Group IVExperimental Group · 4 Interventions: Tocilizumab, Fludarabine, Total Body Irradiation, Melphalan · Intervention Types: Drug, Drug, Radiation, Drug
ATG Group IExperimental Group · 5 Interventions: Tocilizumab, Fludarabine, Anti-thymocyte globulin (rabbit), Total Body Irradiation, Melphalan · Intervention Types: Drug, Drug, Drug, Radiation, Drug
ATG Group IIExperimental Group · 5 Interventions: Tocilizumab, Fludarabine, Anti-thymocyte globulin (rabbit), Total Body Irradiation, Melphalan · Intervention Types: Drug, Drug, Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
FDA approved
Fludarabine
FDA approved
Antithymocyte immunoglobulin (rabbit)
FDA approved
Total Body Irradiation
2006
Completed Phase 3
~890
Melphalan
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years post-transplant

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
998 Previous Clinical Trials
1,331,201 Total Patients Enrolled
Koen van Besien, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
4 Previous Clinical Trials
540 Total Patients Enrolled
Alexandra Gomez Arteaga, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
590 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

What medical conditions is Tocilizumab commonly employed to treat?

"Tocilizumab is efficacious for the management of immunosuppressive treatment, kidney maladies, and amyloidosis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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