← Back to Search

T Cell Depletion

Stem Cell Transplant for Blood Cancer

Phase 1

Waitlist Available

Led By Roni Tamari, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have a Karnofsky or Performance Status ≥ 70%

Patients must be ≥ 18 years old

Must not have

Prior allogenic hematopoietic stem cell transplantation

HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of chemotherapy and low-dose radiation to see if it is safe and effective in treating bone marrow cancer. The CliniMACS device is approved for one type of T cell depletion but not the type being studied in this trial. This trial will help determine if the CliniMACS device should be approved for the other type of T cell depletion.

Who is the study for?

This trial is for adults with certain high-risk blood cancers or severe aplastic anemia who haven't had a previous stem cell transplant. They should be responding to current therapy, have adequate organ function, and not be pregnant or HIV positive. A detailed consent form must be signed indicating willingness to participate.

What is being tested?

The study tests a new low-intensity combination of chemotherapy with low-dose radiation before a T cell depleted allogeneic hematopoietic stem cell transplantation. The goal is to determine safety and effectiveness in curing bone marrow cancer.

What are the potential side effects?

Potential side effects include reactions from the chemotherapy like nausea, fatigue, risk of infection due to immune suppression, possible organ inflammation from radiation exposure, and complications related to stem cell transplantation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am able to care for myself and am up more than 50% of my waking hours.

Select...

I am 18 years old or older.

Select...

My heart, liver, kidneys, and lungs are all working well.

Select...

I have a high-risk blood disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a stem cell transplant from a donor.

Select...

I am HIV positive.

Select...

I have tested positive for HTLV-1.

Select...

I do not have a perfect 10/10 HLA match donor.

Select...

My health is too poor for normal activities or treatments.

Select...

I do not have an active, uncontrolled infection.

Select...

I have received radiation therapy with a high dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days 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

Rate of donor Neutrophil Engraftment

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575

Hypoxia

Febrile neutropenia

Acute kidney injury

Blood bilirubin increased

Diarrhea

Creatinine increased

Sepsis

Hypotension

Left ventricular systolic dysfunction

Bronchopulmonary hemorrhage

Chronic kidney disease

Thromboembolic event

Lung infection

Atrial fibrillation

Atrial flutter

Hemolysis

Hemolytic uremic syndrome

Ejection fraction decreased

Encephalitis infection

Gastric hemorrhage

Gastritis

Heart failure

Mucositis oral

Multi-organ failure

Myalgia

Pleural effusion

Respiratory failure

Small intestine infection

Syncope

Treatment related secondary malignancy

Typhlitis

Fever

Paroxysmal atrial tachycardia

Ascites

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Fludarabine, Transplant, Immunosuppression)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with Myeloid Malignancies & Aplastic AnemiaExperimental Treatment6 Interventions

Transplant conditioning will consist of: ATG (2 mg/kg/day IV on days-8 through-6), fludarabine (30 mg/m\^2/d on days -5 through -2), TBI 400 cGy in 2 divided doses (days -2 and -1) and high dose cyclophosphamide given post stem cell infusion (50 mg/kg on days +3 and +4). One dose of Rituxan (200 mg/m\^2) will be given to reduce the risk of EBV viremia. The donor stem cell product will be derived from the peripheral blood with a target cell infusion of ≥8X10\^6 CD34 cells per recipient kg. Patients will receive post-transplant G-CSF starting on day +7. Patients will undergo donor/recipient bone marrow and peripheral chimerism studies at 30 and 100, and 6, 12, 18 and 24 months post allo HCT and thereafter, at the discretion of the treating clinician. Immune function and disease restaging will be performed at day 100 and 6, 12, 18, and 24 months and as otherwise clinically indicated by the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituxan

2014

Completed Phase 4

~2350

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1240