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Monoclonal Antibodies

Chemoimmunotherapy + Stem Cell Transplant for NK T-cell Lymphoma/Leukemia

Phase < 1
Recruiting
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with lymphoma must have stage III or IV disease
Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights

Study Summary

This trial is studying two different chemotherapy combinations followed by stem cell transplant in treating patients with newly diagnosed stage III-IV non-Hodgkin lymphoma or leukemia.

Who is the study for?
This trial is for children, adolescents, and young adults with advanced T-cell or NK-cell leukemia/lymphoma. They must weigh at least 10 kg, have good heart and lung function, and not be pregnant or breastfeeding. Prior chemotherapy for the current diagnosis disqualifies participation.Check my eligibility
What is being tested?
The study tests two chemoimmunotherapy regimens: modified SMILE plus pembrolizumab (Cohort 1) for NK cell cancers; PRX/BV combined with other drugs (Cohort 2) for peripheral T-cell lymphomas. Successful participants will proceed to allogeneic stem cell transplant.See study design
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk, nausea, hair loss from chemotherapy, allergic reactions to medications used in treatment regimens, and complications related to stem cell transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymphoma is at an advanced stage (III or IV).
Select...
I have been recently diagnosed with a specific type of blood cancer.
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My liver is functioning well, with normal bilirubin and ALT levels.
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I weigh at least 10 kilograms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
overall response rate
Secondary outcome measures
event free survival

Side effects data

From 2016 Phase 2 trial • 303 Patients • NCT02004262
82%
Vaccination site erythema
63%
Chills
56%
Vaccination site induration
56%
Vaccination site pain
54%
Vaccination site oedema
54%
Pyrexia
53%
Fatigue
52%
Vaccination site pruritus
45%
Nausea
34%
Vomiting
32%
Abdominal pain
27%
Constipation
27%
Vaccination site bruising
26%
Decreased appetite
20%
Anaemia
19%
Hypotension
19%
Blood alkaline phosphatase increased
19%
Back pain
19%
Headache
18%
Aspartate aminotransferase increased
16%
Oedema peripheral
14%
Disease progression
14%
Hyponatraemia
14%
Tachycardia
13%
Diarrhoea
13%
Alanine aminotransferase increased
13%
Thrombocytopenia
12%
Pruritus
11%
Weight decreased
11%
Hypertension
10%
Abdominal distension
10%
Insomnia
9%
Ascites
9%
Erythema
9%
Abdominal pain upper
9%
Dehydration
9%
Hypoalbuminaemia
9%
Flatulence
9%
Blood bilirubin increased
9%
Dyspnoea
9%
Pain
7%
Dizziness
7%
Hypokalaemia
7%
Lymphocyte count decreased
7%
Myalgia
6%
Gastrooesophageal reflux disease
6%
Hypomagnesaemia
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Blood creatinine increased
6%
Pain in extremity
6%
Arthralgia
6%
Pulmonary embolism
6%
Hypoxia
6%
Vaccination site vesicles
5%
Hypophosphataemia
5%
Asthenia
5%
Blood albumin decreased
5%
Blood sodium decreased
5%
International normalised ratio increased
5%
Leukocytosis
5%
Deep vein thrombosis
5%
Night sweats
5%
Confusional state
5%
Bile duct obstruction
4%
Abdominal Pain
3%
Dry mouth
3%
Neuropathy peripheral
3%
Dry skin
3%
Sinus tachycardia
3%
Urinary tract infection
3%
Upper respiratory tract infection
2%
Upper gastrointestinal haemorrhage
2%
Cholangitis
2%
Cerebrovascular accident
2%
Cough
2%
Anxiety
2%
Malignant pleural effusion
1%
Neutropenia
1%
Failure to thrive
1%
Myocardial infarction
1%
Hyperbilirubinaemia
1%
Memory impairment
1%
Spinal cord compression
1%
Rash
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Gastritis
1%
Lower gastrointestinal haemorrhage
1%
Device dislocation
1%
Jaundice cholestatic
1%
Pneumonia
1%
Sepsis
1%
Herpes zoster
1%
Klebsiella sepsis
1%
Syncope
1%
Cerebral haemorrhage
1%
Transient ischaemic attack
1%
Haemorrhage
1%
Superior vena cava syndrome
1%
Atrial fibrillation
1%
Acute myocardial infarction
1%
Mental status changes
1%
Hallucination
1%
Gastrointestinal anastomotic complication
1%
Musculoskeletal chest pain
1%
Renal failure acute
1%
Small intestinal obstruction
1%
Death
1%
Hip fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pooled Cohort: Cy/GVAX + CRS-207
Pooled Cohort: CRS-207
Pooled Cohort: Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment5 Interventions
Patients with stage III or IV peripheral T-cell lymphoma-NOS, angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, or enteropathy-associated T-cell lymphoma (other histologies will be considered after case-by-case discussion with Study Chairs and Executive Vice-Chairs). Chemotherapy Regimen: Cycle 1 & 2: Pralatrexate Days 1, 8, and 15, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Cycle 3 & 5: Brentuximab vedotin Day 1, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Cycle 4 & 6: Pralatrexate Days 1, 8, and 15, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Allogeneic Stem Cell Transplant if donor available and not in PD.
Group II: Cohort 1Experimental Treatment5 Interventions
Patients with aggressive NK cell leukemia or stage III or IV extranodal NK/T-cell lymphoma, nasal type. Chemotherapy Regimen: mSMILE: Methotrexate Day 1, Ifosfamide Days 2-4, Dexamethasone Days 2-4, Etoposide Days 2-4, calaspargase pegol Day 8. For patients in CR and no available allogeneic SCT can receive up to 2 additional cycles of mSMILE. Pembrolizumab: For patients in PR/MR/NR/PD after 2 cycles of mSMILE. Allogeneic Stem Cell Transplant if donor available and not in PD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Etoposide
FDA approved
Cyclophosphamide
FDA approved
Methotrexate
FDA approved
Ifosfamide
FDA approved
Doxorubicin
FDA approved
Prednisone
FDA approved
Brentuximab vedotin
FDA approved

Find a Location

Who is running the clinical trial?

New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,021 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,573 Previous Clinical Trials
2,273,237 Total Patients Enrolled
Mitchell Cairo, MDStudy Director - New York Medical College
Fort Washington Medical Center, Holy Cross Germantown Hospital, Holy Cross Hospital of Silver Spring, Inova Alexandria Hospital, Inova Fairfax Hospital, MedStar Southern Maryland, Said M Ali Mdpc, Washington Adventist Hospital
University Of Cairo (Medical School)
Aultman Hospital (Residency)
13 Previous Clinical Trials
296 Total Patients Enrolled

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03719105 — Phase < 1
Peripheral T-Cell Lymphoma Research Study Groups: Cohort 1, Cohort 2
Peripheral T-Cell Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT03719105 — Phase < 1
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03719105 — Phase < 1

Frequently Asked Questions

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

Are there open positions for participants in this trial at present?

"As per the clinicaltrials.gov entry, this investigation is now enrolling individuals; it was first advertised on March 1st 2019 and recently revised on September 26th 2022."

Answered by AI

Does the research protocol encompass individuals aged 85 and younger?

"Patients wishing to be included in this medical trial must fall between the ages of 1 Year and 31 Years. Notably, there are 1059 clinical trials for minors and 4012 available for those over 65 years old."

Answered by AI

Is this investigation something of a pioneering endeavor?

"Since 1997, cyclophosphamide has undergone considerable examination. The first major trial was conducted by Alfacell in the same year and entailed 300 participants. Subsequently, Phase 3 drug approval was granted to this medication before it began its global prevalence; currently 1881 trials are actively taking place across 86 countries and 3466 cities."

Answered by AI

How extensive is the recruitment for this research project?

"Affirmative, the clinical trial is actively recruiting according to information hosted on clinicaltrials.gov. The initial posting was made on March 1st 2019 with a recent edit taking place on September 26th 2022. 40 patients are needed at two distinct locations for this study."

Answered by AI

What uses is cyclophosphamide primarily employed for?

"Cyclophosphamide is typically used to treat macular edema, and may also be beneficial for patients with conditions such as eye inflammation, ulcerative colitis, or varicella-zoster virus acute retinal necrosis."

Answered by AI

Who is eligible to take part in this research experiment?

"To be a successful applicant, individuals ought to have NK-cell leukemia and must fall between the ages of one year and thirty-one. As this trial is in search of around 40 patients, interested parties should make haste to apply."

Answered by AI

What kind of research has been done pertaining to cyclophosphamide?

"Cyclophosphamide was initially investigated in 1997 at Spectrum Health Hospital - Butterworth Campus. Subsequently, there have been 3,429 concluded studies and 1,881 ongoing experiments centered around the drug; many of these taking place in San Francisco, California."

Answered by AI
~10 spots leftby Dec 2025