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Autologous Hematopoietic Stem Cell Transplantation for Diffuse Large B-Cell Lymphoma

Aurora West Allis Medical Center, West Allis, WI
Diffuse Large B-Cell Lymphoma+1 More ConditionsAutologous Hematopoietic Stem Cell Transplantation - Procedure
Eligibility
18+
All Sexes
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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.

Eligible Conditions
  • Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type
  • Diffuse Large B-Cell Lymphoma Activated B-Cell Type (DLBCL-ABC)

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Autologous Hematopoietic Stem Cells
1
Pharmacological Study
1
Copanlisib

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: The time between randomization and death from any cause, assessed up to 5 years (60 months)

Baseline
Body tissue
BCR pathway mutations
Fludeoxyglucose positron emission tomography (FDG-PET) imaging results
GSTT1 null allele expression
MYC translocations
Single-nuclear polymorphisms (SNPs) in the BCNU metabolism or damage repair pathways
Year 5
Time to hematopoietic engraftment
Year 5
Overall survival (OS)
Month 24
24-month progression-free survival (PFS), defined as the proportion of patients who are alive and progression-free 2 years from randomization
Year 5
PFS
Up to 60 months
Incidence of hematologic toxicity of ibrutinib therapy
Incidence of secondary malignancies
Response rate using the Lugano classification
Treatment-related mortality

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Autologous Hematopoietic Stem Cells
1
Pharmacological Study
1
Copanlisib

Side Effects for

Tandem HST (CEM), Randomly Assigned
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%11600-Alanine aminotransferase increased
7%13500-Anorexia
7%42700-Hypocalcemia
7%41400-Hyperglycemia
6%73700-Sepsis
6%53700-Lymphocyte count decreased
6%43300-Hyponatremia
6%15000-Aspartate aminotransferase increased
4%25700-Diarrhea
3%10300-Abdominal pain
3%20500-Catheter related infection
3%37500-GGT increased
3%41600-Hyperkalemia
3%65900-Pleural effusion
3%57600-Nausea
3%59700-Oral pain
2%38900-Hearing impaired
2%17200-Blood and lymphatic system disorders - Other specify
2%14900-Ascites
2%75700-Small intestinal obstruction
2%87900-Vomiting
2%43900-Hypoxia
2%43600-Hypotension
1%44200-Ileal obstruction
1%71000-Renal and urinary disorders - Other specify
1%66500-Portal hypertension
1%25600-Device related infection
1%38800-Headache
1%37300-Generalized muscle weakness
1%41300-Hypercalcemia
1%58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%81200-Treatment related secondary malignancy
1%20100-Cardiac disorders - Other specify
1%13400-Anorectal infection
1%54900-Metabolism and nutrition disorders - Other specify
1%72700-Right ventricular dysfunction
1%22100-Colitis
1%62500-Pelvic infection
1%63100-Pericardial effusion
1%31900-Eye disorders - Other specify
1%37200-General disorders and administration site conditions - Other specify
1%40000-Hepatic failure
1%10900-Activated partial thromboplastin time prolonged
1%45800-INR increased
1%88200-Weight gain
1%69000-Pulmonary hypertension
1%71500-Respiratory failure
1%26600-Duodenal obstruction
1%31200-Esophagitis
1%75600-Small intestinal mucositis
1%81900-Typhlitis
1%33900-Fever
1%35500-Gallbladder pain
1%40600-Hepatobiliary disorders - Other specify
1%12000-Allergic reaction
1%13100-Anaphylaxis
1%44700-Immune system disorders - Other specify
1%53100-Lung infection
1%75200-Skin infection
1%83100-Urinary tract infection
1%14500-Arterial injury
1%66800-Postoperative hemorrhage
1%11800-Alkaline phosphatase increased
1%17400-Blood bilirubin increased
1%24100-Creatinine increased
1%42500-Hyperuricemia
1%43500-Hypophosphatemia
1%15300-Ataxia
1%63900-Peripheral motor neuropathy
1%11100-Acute kidney injury
1%62600-Pelvic pain
1%11300-Adult respiratory distress syndrome
1%29700-Epistaxis
1%65300-Pharyngolaryngeal pain
1%66300-Pneumonitis
1%78100-Stridor
1%68400-Pruritus
1%69700-Rash maculo-papular
1%82300-Upper respiratory infection
1%51700-Left ventricular systolic dysfunction
1%27800-Dyspnea
1%58100-Nervous system disorders - Other specify
1%29000-Encephalopathy
1%56600-Myelitis
1%42100-Hypertension
1%24700-Dehydration
1%43200-Hypomagnesemia
1%29500-Enterocolitis infectious
1%31800-Extrapyramidal disorder
1%34000-Fibrinogen decreased
1%52600-Lipase increased
1%73900-Serum amylase increased
1%42600-Hypoalbuminemia
1%23000-Confusion
1%10700-Acidosis
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT00567567) in the Tandem HST (CEM), Randomly Assigned ARM group. Side effects include: 58300-Neutrophil count decreased with 84%, 65800-Platelet count decreased with 70%, 43100-Hypokalemia with 20%, 44800-Infections and infestations - Other specify with 18%, 33300-Febrile neutropenia with 18%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2 Treatment Groups

Arm I (ibrutinib, chemotherapy, autoHCT)
1 of 2
Arm II (placebo, chemotherapy, autoHCT)
1 of 2

Experimental Treatment

Non-Treatment Group

302 Total Participants · 2 Treatment Groups

Primary Treatment: Autologous Hematopoietic Stem Cell Transplantation · Has Placebo Group · Phase 3

Arm I (ibrutinib, chemotherapy, autoHCT)Experimental Group · 10 Interventions: Cyclophosphamide, Autologous Hematopoietic Stem Cell Transplantation, Autologous Bone Marrow Transplantation, Ibrutinib, Melphalan, Pharmacogenomic Study, Etoposide, Carmustine, Cytarabine, Laboratory Biomarker Analysis · Intervention Types: Drug, Procedure, Procedure, Drug, Drug, Other, Drug, Drug, Drug, Other
Arm II (placebo, chemotherapy, autoHCT)PlaceboComparator Group · 10 Interventions: Cyclophosphamide, Autologous Hematopoietic Stem Cell Transplantation, Autologous Bone Marrow Transplantation, Melphalan, Placebo Administration, Pharmacogenomic Study, Etoposide, Carmustine, Cytarabine, Laboratory Biomarker Analysis · Intervention Types: Drug, Procedure, Procedure, Drug, Other, Other, Drug, Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Autologous Hematopoietic Stem Cell Transplantation
2007
Completed Phase 3
~1680
Autologous Bone Marrow Transplantation
2013
Completed Phase 2
~660
Ibrutinib
FDA approved
Mechlorethamine
FDA approved
Etoposide
FDA approved
Carmustine
FDA approved
Cytarabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the time between randomization and death from any cause, assessed up to 5 years (60 months)

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,272 Previous Clinical Trials
41,230,426 Total Patients Enrolled
Charalambos B AndreadisPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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