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Chemotherapy

Allogeneic Hematopoietic Stem Cell Transplantation for Blood Cancers

Phase 1 & 2
Waitlist Available
Led By Issa Khouri
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with B-cell hematological malignancies who are eligible for allogeneic transplantation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing inotuzumab ozogamicin given with fludarabine phosphate, bendamustine hydrochloride, and rituximab before a donor stem cell transplant in treating patients with lymphoid malignancies.

Eligible Conditions
  • Blood Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a type of blood cancer that can be treated with a bone marrow transplant using cells from someone else.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicity
Maximum-tolerated dose (MTD) of inotuzumab ozogamicin
Secondary outcome measures
Cumulative incidence of acute and chronic graft versus host disease (GVHD)
Objective overall response (complete remission and partial remission)
Overall survival (OS)
+1 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575
5%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (transplant)Experimental Treatment10 Interventions
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Bone Marrow Transplantation
2009
Completed Phase 2
~470
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Methotrexate
2013
Completed Phase 4
~3800
Rituximab
1999
Completed Phase 4
~1880
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Anti-Thymocyte Globulin
2009
Completed Phase 4
~980
Tacrolimus
2011
Completed Phase 4
~4740
Bendamustine Hydrochloride
2011
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,619 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,422 Total Patients Enrolled
Issa KhouriPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
81 Total Patients Enrolled

Frequently Asked Questions

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

Are there precedents for this type of blood cell transplant surgery?

"Across the world, there are 1083 ongoing trials studying Allogeneic Hematopoietic Stem Cell Transplantation with 195 of those in Phase 3. Although many of these trials originated in Philadelphia, Pennsylvania, they are now being conducted in 24605 different locations."

Answered by AI

What type of illnesses or injuries does Allogeneic Hematopoietic Stem Cell Transplantation help with?

"Allogeneic Hematopoietic Stem Cell Transplantation can not only be used to treat dermatitis, but also atopic conditions like multiple sclerosis. Additionally, it has shown efficacy in the treatment of b-cell lymphomas and polyangium."

Answered by AI

How can I join this clinical research project?

"The patients who will be eligible for this trial must have hematologic neoplasms and be between the ages of 18-70. So far, 27 people have been accepted into the study."

Answered by AI

How many people are total in this clinical study?

"Recruitment for this trial has ceased. The first posting was on October 29th, 2012 and the most recent edit was made on May 4th, 2022. However, there are 368 other studies currently recruiting patients with hematologic neoplasms and 1083 studies regarding Allogeneic Hematopoietic stem cell transplantation that are still looking for participants."

Answered by AI

Are people over the age of 40 eligible to participate in this research project?

"This trial includes a broad age range of 18 to 70 years old, as specified in the inclusion criteria."

Answered by AI

What is the end-goal of this clinical trial?

"The primary outcome of this trial is to assess the maximum-tolerated dose (MTD) of inotuzumab ozogamicin over a period of up to 30 days. Secondary outcomes include overall survival (OS), which will be estimated using Kaplan-Meier survival curves, and cumulative incidence of acute and chronic graft versus host disease (GVHD). The association between disease and clinical characteristics and the survival outcomes will be assessed using Cox proportional hazards regression methodology."

Answered by AI

Can people with the relevant medical condition still enroll in this research project?

"The clinical trial in question is not actively recruiting patients according to the information found on clinicaltrials.gov. The trial was initially posted on 10/29/2012 and was last edited on 5/4/2022. Even though this particular study isn't looking for participants, there are 1451 other trials that are currently active."

Answered by AI
~2 spots leftby Mar 2025