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Personalized NK Cell Therapy for Blood Cancer

Phase 2
Recruiting
Led By Katy Rezvani
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 options for treatment that are known to be curative are not eligible
Chronic myeloid leukemia (CML) second chronic phase or accelerated phase
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial will test a new way of using cord blood to treat patients with leukemia, lymphoma, or multiple myeloma who have received chemotherapy and a cord blood transplant.

Who is the study for?
This trial is for patients aged 15-80 with various blood cancers or myelodysplastic syndromes who have not responded well to standard treatments. They must be physically able to tolerate the transplant, with specific heart, kidney, and liver function requirements. Women of childbearing age must test negative for pregnancy. Those with curative treatment options elsewhere or certain serious health conditions are excluded.Check my eligibility
What is being tested?
The study tests personalized NK cell therapy following chemotherapy and umbilical cord blood transplantation in patients with leukemia, lymphoma, multiple myeloma, or myelodysplastic syndrome. It aims to see if NK cells can kill remaining tumor cells and reduce graft versus host disease after transplant.See study design
What are the potential side effects?
Potential side effects include reactions from the body's immune response to new cells, complications from high-dose chemotherapy like nausea and hair loss, increased risk of infections due to weakened immunity post-transplantation, and possible organ damage related to the conditioning regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any curative treatment options available.
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My CML is in the second chronic or accelerated phase.
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I have a type of MDS that might need a transplant or falls into one of several high-risk categories.
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My non-Hodgkin's lymphoma is in remission or has relapsed, but I don't have curative treatment options.
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My multiple myeloma is advanced and needs treatment.
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I have a specific type of blood cancer, such as AML, that is at high risk or beyond first remission.
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My heart pumps at least 40% of its blood each time it beats.
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My lung function tests show at least half the normal capacity for oxygen exchange.
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I can care for myself but cannot carry on normal activity or do active work.
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My kidney function is normal or meets the minimum required level.
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I am not pregnant and have had a period in the last 12 months.
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My SLL or CLL has worsened despite two standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Progression free survival (PFS) time in C1 patients
Progression free survival (PFS) time in C2C2 patients
Secondary outcome measures
Incidence of graft-versus host disease
Incidence of infection
Incidence of transplant related mortality
+1 more

Side effects data

From 2022 Phase 2 trial • 6 Patients • NCT03096782
100%
Mucositis
100%
Nausea
100%
Rash
67%
Diarrhea
67%
Hypertension
67%
HHV6 infection
50%
Constipation
50%
Neutropenic fever
50%
Urinary Tract Infection (BK virus)
50%
Vomiting
50%
Dyspnea
50%
Headache
50%
Insomnia
33%
Neuropathy
33%
Chills
33%
Congestion
33%
Platelet Infusion Reaction
33%
Tachycardia
33%
Hyperglycemia
17%
Anxiety
17%
Malnutrition
17%
Vaginal irritation
17%
Joint swelling
17%
Myalgia
17%
Dysuria
17%
Hemorrhoids
17%
Sore Throat
17%
Anorexia
17%
Arm pain
17%
Arthralgia
17%
BK cystitis
17%
BK virus
17%
Blurry vision
17%
Bone pain
17%
Chest tightness
17%
CMV infection
17%
Cough
17%
Crackles to right lung
17%
Deconditioning
17%
Decreased Appetite
17%
Febrile neutropenia
17%
Fever
17%
Fluid Imbalance
17%
Fluid Overload
17%
Flu-like Symptoms
17%
Folliculitis
17%
Generalized body aches
17%
Hand-foot syndrome
17%
Norovirus
17%
Parainfluenza URI
17%
Peripheral edema
17%
Weakness
17%
Transaminitis
17%
Hypotension
17%
Indigestion (dyspepsia)
17%
Ingrown toenail
17%
Blurred Vision
17%
Abdominal pain
17%
Abnormal coagulopathy
17%
Dry Eyes
17%
DVT (thrombosis)
17%
E. Coli pneumonia
17%
Epistaxis
17%
Fatigue
17%
Hematochezia
17%
Hyperbilirubinemia
17%
Int elevated ALT
17%
Lower back pain
17%
Migraine
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy and Cord Blood Transfusion

Trial Design

3Treatment groups
Experimental Treatment
Group I: Reduced intensity regimen 3Experimental Treatment6 Interventions
Patients receive anti-thymocyte globulin IV over 4 hours on days -7 and -6, fludarabine phosphate IV over 1 hour on days -5 to -2, and melphalan IV over 30 minutes on day -2. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.
Group II: Non-myeloablative regimen 2Experimental Treatment8 Interventions
Patients with CD20 positive malignancies receive rituximab IV over 6 hours on day -9. Patients receive anti-thymocyte globulin IV over 4 hours on days -8 and -7, fludarabine phosphate IV over 1 hour on days -6 to -3, and cyclophosphamide IV over 3 hours on day -6 and undergo TBI on day -1 at the discretion of the investigator(s). UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.
Group III: Myeloablative regimen 1Experimental Treatment8 Interventions
Patients receive anti-thymocyte globulin IV over 4 hours on days -9 and -8, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -7 to -4. Patients undergo TBI on day -3. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Umbilical Cord Blood Transplantation
2009
Completed Phase 2
~470
Anti-Thymocyte Globulin
2009
Completed Phase 4
~980
Busulfan
2008
Completed Phase 3
~1120
Clofarabine
2007
Completed Phase 3
~1130
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Melphalan
2008
Completed Phase 3
~1500
Rituximab
1999
Completed Phase 4
~1880
Total-Body Irradiation
1997
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,221 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,781 Total Patients Enrolled
Katy RezvaniPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Umbilical Cord Blood Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT02727803 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Non-myeloablative regimen 2, Reduced intensity regimen 3, Myeloablative regimen 1
Acute Myeloid Leukemia Clinical Trial 2023: Umbilical Cord Blood Transplantation Highlights & Side Effects. Trial Name: NCT02727803 — Phase 2
Umbilical Cord Blood Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT02727803 — Phase 2

Frequently Asked Questions

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

What is the current participant count for this clinical experiment?

"Affirmative, clinicaltrials.gov confirms that this investigation is presently enrolling participants. It was initially posted on May 19th 2016 and had its most recent update on October 20th 2022; 100 persons are needed at a single site to complete the study."

Answered by AI

What medical applications does Umbilical Cord Blood Transplantation usually entail?

"Through the use of Umbilical Cord Blood Transplantation, patients suffering from chronic lymphocytic leukemia (CLL), disseminated neuroblastoma, and other forms of cancer can be treated."

Answered by AI

What is the intended outcome of this research endeavor?

"The main outcome of this 4 year-long study is to determine the Progression Free Survival (PFS) time in patients with C1. Additionally, researchers will be exploring Transplant Related Mortality, Graft Versus Host Disease and Infection rates by utilizing Bayesian Regression Models that factor in patient covariates such as their KIR haplotype, age, diagnosis, HLA match and CMV status. The data collected for these secondary outcomes will then be tabulated and analyzed through regression modeling."

Answered by AI

Is it possible for me to enroll in this research endeavor?

"This medical trial is open to individuals between the ages of 15 and 80 with refractory adult acute lymphoblastic leukemia. Furthermore, applicants must meet any additional criteria including: AML induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics), secondary leukemia from prior chemotherapy/MDS, MDA transfusion dependency that does not respond to hypomethylating agents; primary or therapy related MDS, ALL induction failure/primary refractory treatment beyond first remission; NHL in second or third complete remission/relapse post autologous hematopoietic stem cell"

Answered by AI

Is enrollment open to those aged fifty and above in this research endeavor?

"This research is searching for participants aged 15 or above, up to a cut-off of 80 years."

Answered by AI

Is Umbilical Cord Blood Transplantation sanctioned by the FDA?

"Umbilical Cord Blood Transplantation's safety rating on the Power scale is 2, as there have been studies to back its safety but no clinical trials assessing efficacy."

Answered by AI

Is there an ongoing recruitment process for this research study?

"According to the clinicaltrials.gov database, this medical trial is actively seeking participants and has been open for recruitment since May 19th 2016 with updates being made as recently as October 20th 2022."

Answered by AI

Could you provide an overview of the research done on Umbilical Cord Blood Transplantation?

"Currently, 1216 clinical trials are in progress around Umbilical Cord Blood Transplantation with 226 of these trials at the Phase 3 stage. The majority of investigations for this procedure take place near Philadelphia, PA but there are 37877 locations worldwide where such studies occur."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Personalized NK Cell Therapy in CBT
2016. "Personalized NK Cell Therapy in CBT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02727803.
~12 spots leftby May 2025
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