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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Stem Cell Transplant for Lymphoma

Phase 3
Waitlist Available
Led By Charalambos B Andreadis
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients should not require concurrent therapeutic doses of steroids (> 20 mg of prednisone/day or equivalent) unless they need them for the indications; steroids should be discontinued for 14 days before starting protocol treatment
Use of HIV protease inhibitors as part of the anti-HIV regimen OR as a pharmacologic booster is not allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the time between randomization and death from any cause, assessed up to 5 years (60 months)
Awards & highlights

Study Summary

This trial is studying whether adding ibrutinib to chemotherapy before and after stem cell transplant helps the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.

Who is the study for?
Adults with relapsed or refractory diffuse large B-cell lymphoma eligible for stem cell transplant can join. They must have responded at least partially to prior chemotherapy, be in good physical condition, and not have severe heart, lung, liver issues or active infections like hepatitis B/C or HIV with complications. Pregnant/nursing individuals and those on certain drugs are excluded.Check my eligibility
What is being tested?
The trial is testing if adding the drug Ibrutinib to standard high-dose chemotherapy before and after a stem cell transplant can improve outcomes in patients with difficult-to-treat lymphoma compared to a placebo.See study design
What are the potential side effects?
Ibrutinib may cause side effects such as diarrhea, bleeding problems, high blood pressure, fatigue, muscle and bone pain. It might also increase the risk of infections due to its effect on cancer cells' growth pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on high doses of steroids, or can stop them 14 days before treatment.
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I am not using HIV protease inhibitors for my HIV treatment.
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I can take care of myself and am up and about more than half of my waking hours.
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My heart functions well during normal activities and I'm over 60 with an LVEF of 40% or more.
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My condition worsened or didn't respond to previous chemotherapy that included anthracyclines.
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I am using or willing to use effective birth control during and for one month after the study.
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I don't use strong medication that affects liver enzyme levels regularly.
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I am not taking Zidovudine.
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I have a bleeding disorder.
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I have hepatitis B or C but my PCR test for the virus is negative.
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I am not taking HIV medication that includes a booster like cobicistat.
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I do not have multi-drug resistant HIV.
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My tests show early signs of a bone marrow disorder before starting treatment.
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I have not taken warfarin or similar drugs in the last 28 days.
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I have significant liver problems (Child-Pugh class B or C).
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My lung function, measured by FEV1, is at least 40% of the expected value.
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My lymphoma is confirmed as non-GCB diffuse large B-cell type.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the time between randomization and death from any cause, assessed up to 5 years (60 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and the time between randomization and death from any cause, assessed up to 5 years (60 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
24-month progression-free survival (PFS), defined as the proportion of patients who are alive and progression-free 2 years from randomization
Secondary outcome measures
Incidence of hematologic toxicity of ibrutinib therapy
Incidence of secondary malignancies
Overall survival (OS)
+4 more
Other outcome measures
Body tissue
BCR pathway mutations
Fludeoxyglucose positron emission tomography (FDG-PET) imaging results
+3 more

Side effects data

From 2022 Phase 3 trial • 665 Patients • NCT00567567
84%
58300-Neutrophil count decreased
70%
65800-Platelet count decreased
20%
43100-Hypokalemia
18%
44800-Infections and infestations - Other specify
18%
33300-Febrile neutropenia
17%
88500-White blood cell decreased
13%
13200-Anemia
9%
55600-Mucositis oral
7%
42700-Hypocalcemia
7%
13500-Anorexia
7%
11600-Alanine aminotransferase increased
7%
41400-Hyperglycemia
6%
15000-Aspartate aminotransferase increased
6%
43300-Hyponatremia
6%
73700-Sepsis
6%
53700-Lymphocyte count decreased
4%
25700-Diarrhea
3%
57600-Nausea
3%
65900-Pleural effusion
3%
37500-GGT increased
3%
41600-Hyperkalemia
3%
10300-Abdominal pain
3%
20500-Catheter related infection
3%
59700-Oral pain
2%
38900-Hearing impaired
2%
43900-Hypoxia
2%
17200-Blood and lymphatic system disorders - Other specify
2%
14900-Ascites
2%
75700-Small intestinal obstruction
2%
87900-Vomiting
2%
43600-Hypotension
1%
23000-Confusion
1%
71500-Respiratory failure
1%
69700-Rash maculo-papular
1%
42600-Hypoalbuminemia
1%
66300-Pneumonitis
1%
26600-Duodenal obstruction
1%
34000-Fibrinogen decreased
1%
45800-INR increased
1%
73900-Serum amylase increased
1%
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%
56600-Myelitis
1%
75600-Small intestinal mucositis
1%
66800-Postoperative hemorrhage
1%
43500-Hypophosphatemia
1%
37300-Generalized muscle weakness
1%
81200-Treatment related secondary malignancy
1%
31200-Esophagitis
1%
83100-Urinary tract infection
1%
24100-Creatinine increased
1%
11100-Acute kidney injury
1%
62600-Pelvic pain
1%
65300-Pharyngolaryngeal pain
1%
31900-Eye disorders - Other specify
1%
10900-Activated partial thromboplastin time prolonged
1%
11800-Alkaline phosphatase increased
1%
42500-Hyperuricemia
1%
17400-Blood bilirubin increased
1%
63100-Pericardial effusion
1%
72700-Right ventricular dysfunction
1%
37200-General disorders and administration site conditions - Other specify
1%
40000-Hepatic failure
1%
88200-Weight gain
1%
41300-Hypercalcemia
1%
54900-Metabolism and nutrition disorders - Other specify
1%
71000-Renal and urinary disorders - Other specify
1%
69000-Pulmonary hypertension
1%
20100-Cardiac disorders - Other specify
1%
22100-Colitis
1%
44200-Ileal obstruction
1%
81900-Typhlitis
1%
33900-Fever
1%
35500-Gallbladder pain
1%
40600-Hepatobiliary disorders - Other specify
1%
66500-Portal hypertension
1%
12000-Allergic reaction
1%
13100-Anaphylaxis
1%
44700-Immune system disorders - Other specify
1%
13400-Anorectal infection
1%
25600-Device related infection
1%
29500-Enterocolitis infectious
1%
53100-Lung infection
1%
62500-Pelvic infection
1%
75200-Skin infection
1%
82300-Upper respiratory infection
1%
14500-Arterial injury
1%
15300-Ataxia
1%
38800-Headache
1%
63900-Peripheral motor neuropathy
1%
11300-Adult respiratory distress syndrome
1%
29700-Epistaxis
1%
78100-Stridor
1%
68400-Pruritus
1%
51700-Left ventricular systolic dysfunction
1%
27800-Dyspnea
1%
58100-Nervous system disorders - Other specify
1%
29000-Encephalopathy
1%
42100-Hypertension
1%
24700-Dehydration
1%
43200-Hypomagnesemia
1%
31800-Extrapyramidal disorder
1%
52600-Lipase increased
1%
10700-Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tandem HST (CEM), Randomly Assigned
Single HST (CEM)
Not Assigned

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (ibrutinib, chemotherapy, autoHCT)Experimental Treatment10 Interventions
CONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen. BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1. CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0. CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (placebo, chemotherapy, autoHCT)Placebo Group10 Interventions
CONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I. TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0. CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~1890
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1800
Carmustine
1990
Completed Phase 3
~1790
Melphalan
2008
Completed Phase 3
~1500
Etoposide
2010
Completed Phase 3
~2440
Cyclophosphamide
1995
Completed Phase 3
~3770
Cytarabine
2016
Completed Phase 3
~3310
Autologous Bone Marrow Transplantation
2013
Completed Phase 2
~660

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,708 Previous Clinical Trials
40,932,427 Total Patients Enrolled
Charalambos B AndreadisPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02443077 — Phase 3
Diffuse Large B-Cell Lymphoma Research Study Groups: Arm I (ibrutinib, chemotherapy, autoHCT), Arm II (placebo, chemotherapy, autoHCT)
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT02443077 — Phase 3
Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02443077 — Phase 3

Frequently Asked Questions

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

What is the FDA's opinion on Autologous Hematopoietic Stem Cell Transplantation?

"Autologous Hematopoietic Stem Cell Transplantation is considered safe, as it has received a score of 3."

Answered by AI

What are some precedents for this type of blood-based stem cell therapy?

"City of Hope Comprehensive Cancer Center first studied Autologous Hematopoietic Stem Cell Transplantation in 1997. So far, 2255 clinical trials have completed with 1331 still active. Many of these studies are based out of Clackamas, Oregon."

Answered by AI

Are there any current vacancies in this trial for new participants?

"That is correct, the online clinical database has this study listed as 'seeking participants'. The trial was created on 7/6/2016 and updated for the last time on 11/11/2022. They are looking for 302 individuals from 100 different locations to take part in the study."

Answered by AI

How many people are being given the opportunity to participate in this clinical trial?

"That is correct. The trial, which was originally posted on July 6th 2016 and updated November 11th 2020, is still recruiting patients at 100 sites across the United States of America. They are looking for a total of 302 participants."

Answered by AI

What are the most frequent diagnoses that Autologous Hematopoietic Stem Cell Transplantation is used to treat?

"Autologous Hematopoietic Stem Cell Transplantation is a standard treatment for various lung cancers, as well as other diseases such as small cell lung cancer (sclc), multiple sclerosis, leukemia, myelocytic, and acute."

Answered by AI

In how many different settings is this experiment being conducted today?

"There are 100 medical centres enrolling patients for this trial, with locations in Clackamas, Hazleton and Norton Shores. If you wish to minimize travel time and distance, please select the nearest site to your location."

Answered by AI
~33 spots leftby May 2025