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Cell Therapy
Stem Cell Transplant for Leukemia (HAPLOTAB Trial)
N/A
Recruiting
Led By Erin Morales, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lack of suitable conventional donor (10/10 HLA matched related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an HLA-matched unrelated donor (excluding cord blood unit availability)
Lansky/Karnofsky score > 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year post-hct
Awards & highlights
HAPLOTAB Trial Summary
This trial will test a new, safer way to do a stem cell transplant to treat underlying medical conditions and eliminate the risk of graft versus host disease.
Who is the study for?
This trial is for patients without a fully matched donor or with rapidly progressing diseases who need a stem cell transplant. It's open to those with certain blood cancers, hemoglobin disorders like thalassemia or sickle cell disease, severe viral infections, immune deficiencies, and bone marrow failures. Participants must be in good enough health to undergo the procedure.Check my eligibility
What is being tested?
The study tests a new way of doing transplants using half-matched family donors' blood cells treated to reduce GvHD risk. The treatment uses CliniMACS® TCRα/β-Biotin System to remove specific immune cells that could cause complications post-transplant.See study design
What are the potential side effects?
Potential side effects may include reactions related to the transplantation process such as infection risks due to weakened immunity, graft failure, mild-to-severe GvHD despite preventive measures taken during the procedure, and possible infusion-related reactions.
HAPLOTAB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't have a perfect match donor or my disease is progressing too quickly to wait for one.
Select...
I am mostly active and can do things for myself.
Select...
I have a serious blood disorder or bone marrow failure.
HAPLOTAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year post-hct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year post-hct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of acute graft versus host disease (GvHD) by grades
Rate of neutrophil engraftment
Rate of platelet engraftment
Secondary outcome measures
Overall survival (OS)
Rate of transplant-related mortality (TRM)
Side effects data
From 2020 Phase 3 trial • 324 Patients • NCT0070382068%
Febrile neutropenia (fever of unknown origin: not clinically or microbiologically documented)
53%
Infection (documented clinically or microbioogically) with Grade 3 or 4 neutrophils (ANC<1.0x10e9/L)
34%
Potassium, serum-low (hypokalemia)
25%
ALT, SGPT (serum glutamic pyruvic transaminase)
16%
Colitis, infectious (e.g., Clostridium difficile)
15%
Infection (documented clinically or microbiologically documented, ANC<1.0x10e9/L, fever>38.5C),blood
15%
AST, SGOT (serum glutamic oxaloacetic transaminase)
13%
Phosphate, serum-low (hypophosphatemia)
12%
Glucose, serum-high (hyperglycemia)
12%
Calcium, serum-low (hypocalcemia)
8%
Anorexia
8%
Allergic reaction/hypersensitivity (including drug fever)
8%
Hypoxia
8%
Hypertension
8%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
7%
Nausea
6%
Sodium, serum-low (hyponatremia)
6%
Hypotension
5%
Infection with normal ANC or Grade 1 or 2 neutrophils
5%
Diarrhea
5%
Bilirubin (hyperbilirubinemia)
5%
Allbumin, serum-low (hypoalbuminemia)
5%
Tumor lysis syndrome
5%
Rash/desquamation
5%
Typhlitis (cecal inflammation)
5%
Vomiting
5%
Colitis
4%
Mucositis/stomatitis (clinical exam), oral cavity
4%
Pain, rectum
4%
Speech impairment (e.g., dysphasia or aphasia)
3%
Pain, head/headache
3%
Ataxia (incoordination)
3%
Sodium, serum-high (hypernatremia)
3%
Pain, Abdomen NOS
3%
Acidosis (metabolic or respiratory)
3%
Mucositis/stomatitis (functional/symptomatic), oral cavity
2%
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
2%
GGT (gamma-Glutamyl transpeptidase)
2%
Neuropathy: motor
2%
Esophagitis
2%
Gastritis (including bile reflux gastritis)
2%
Magnesium, serum-low (hypomagnesemia)
2%
Alkalosis (metabolic or respiratory)
2%
Syncope (fainting)
2%
Infection with unknown ANC, blood
2%
Uric acid, serum-high (hyperuricemia)
2%
Enteritis (inflammation of the small bowel)
2%
Potassium, serum-ghigh (hyperkalemia)
2%
Hemorrhage, pulmonary/upper respiratory, nose
2%
Prolonged QTc interval
2%
Weight loss
2%
Injection site reaction/extravasation changes
2%
Left ventricular systolic dysfunction
2%
Pericardial effusion (non-malignant)
2%
Thrombosis/thrombus/embolism
2%
Hematoma
2%
PTT (Partial Thromboplastin Time)
2%
Renal failure
2%
Confusion
2%
Cholecystitis
2%
Dysphagia (difficulty swallowing)
2%
Encephalopathy
2%
Infection - other
2%
Adult Respiratory Distress Syndrome (ARDS)
2%
Pneumonitis/pulmonary infiltrates
2%
Metabolic/Laboratory
2%
CNS cerebrovascular ischemia
2%
Pulmonary/upper respiratory - other
1%
Seizure
1%
Calcium, serum-high (hypercalcemia)
1%
Magnesium, serum-high (hypermagnesemia)
1%
Distension/bloating, abdominal
1%
Gastrointestinal - Other
1%
Lipase
1%
Fibrinogen
1%
Supraventricular and nodal arrhythmia, sinus tachycardia
1%
Hemorrhage, GI, Lower GI NOS
1%
Somnolence/depressed level of consciousness
1%
Neuropathy: cranial, CN IX Motor-pharynx; sensory-ear, pharynx, tongue
1%
Neurology - other
1%
Infection with unknown ANC, catheter-related
1%
Infection with unknown ANC, urinary tract NOS
1%
DIC (disseminated intravascular coagulation)
1%
Neutrophils/granulocytes (ANC/AGC)
1%
Ocular surface disease
1%
Keratitis (corneal inflammation/corneal ulceration)
1%
Vision-photophobia
1%
Death not associated with CTCAE term, multi-organ failure
1%
Constitutional symptoms - other
1%
Pain - other
1%
Death not associated with CTCAE term, sudden death
1%
Dyspnea (shortness of breath)
1%
Pleural effusion (non-malignant)
1%
Apnea
1%
Valvular heart disease
1%
Supraventricular and nodal arrhythmia, sinus bradycardia
1%
Left ventricular diastolic dysfunction
1%
Rash: acne/acneiform
1%
Pruritus/itching
1%
Acute vascular leak syndrome
1%
Pain, back
1%
Urinary frequency/urgency
1%
Mood alteration, euphoria
1%
Tinnitus
1%
Pain, vagina
1%
Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS
1%
Right ventricular dysfunction (cor pulmonale)
1%
Pain, extremity-limb
1%
INR (International Normalized Ratio of prothrombin time)
1%
Perforation, GI, appendix
1%
Pain, dental/teeth/peridontal
1%
Pain, stomach
1%
Mucotitis/stomatitis (functional/symptomatic), esophagus
1%
Pain, lip
1%
Neuropathy: sensory
1%
Hemorrhage, CNS
1%
Hemorrhage, GU, iuterus
1%
Dehydration
1%
Amylase
1%
Creatinine
1%
CNS necrosis/cystic progression
1%
Hemorrhage, GI, Oral cavity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cytarabine+Daunorubicin+Etoposide
Clofarabine+Cytarabine
Stem Cell Donors
HAPLOTAB Trial Design
1Treatment groups
Experimental Treatment
Group I: Alpha beta+ T cell depleted CD34+ stem cellsExperimental Treatment1 Intervention
The patient will be receiving a donor stem cell transplant with a preceding conditioning regimen (chemotherapy with, or without, radiation). The investigators will be specially treating the donor's blood cells used for the stem cell transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CliniMACS
2005
Completed Phase 3
~770
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,205 Total Patients Enrolled
30 Trials studying Leukemia
1,337 Patients Enrolled for Leukemia
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,770 Total Patients Enrolled
22 Trials studying Leukemia
478 Patients Enrolled for Leukemia
The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,328 Total Patients Enrolled
21 Trials studying Leukemia
454 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have a perfect match donor or my disease is progressing too quickly to wait for one.My heart is weak, with an ejection fraction below 40%.I do not have any serious uncontrolled health or mental conditions.I am currently on immunosuppressive drugs for GVHD from a past transplant.I am currently living with HIV.My kidney function is severely reduced.My liver tests are significantly higher than normal.I do not have an active infection that would prevent me from receiving strong chemotherapy or a transplant.I have severe lung disease with very low lung function.I am currently pregnant or breastfeeding.I am mostly active and can do things for myself.I have a serious blood disorder or bone marrow failure.I have severe graft versus host disease from a past transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Alpha beta+ T cell depleted CD34+ stem cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative presently recruiting participants?
"Clinicaltrials.gov indicates that this medical trial is not presently open to new participants, with its initial post date of April 1st 2022 and last update on February 2nd 2022. Nevertheless, there are currently 3,465 other trials actively recruiting patients."
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