A Phase 2 interventional study of Genistein and Placebo in Lymphoma, Childhood Lymphoma and Solid Tumor, sponsored by University of Virginia. Terminated at 1 site in United States. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by University of Virginia · Phase 2, Interventional, and Supportive care
Among 1,909 studies in Lymphoma with a site in United States — 163 open to participants now, 289 under way, 15 of them phase 3. Lymphoma · United States.
Among the 1,909 studies in Lymphoma with a site in United States, this one is the 1,454th largest by enrollment of the 1,594 interventional ones, is one of 73 that started in 2016, is one of 668 in phase 2, and was the 1,384th registered.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's enrollment of 4 is below the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →163 of the 1,909 studies in Lymphoma with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 347 Lymphoma studies recruiting now, 227 (65%) set no upper age limit and 79 (23%) stop at 75 or younger; 78 take children under 18; 20 take healthy volunteers.
This study: 1 Year to 21 Years · all sexes · no healthy volunteers.
The full table on the hub →1,909 studies; the count open now beside each. This study's row is marked.
First in 1986; this study’s year is marked. 73 started in 2016.
Median enrollment 36 across the 1,594 interventional studies, 120 across the 160 observational. Of the 1,505 that completed or were terminated, 581 (39%) have results posted.
514 of 1,909 have an industry lead sponsor. The 10 most frequent:
University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
University of Virginia has 3 studies filed under Lymphoma — fewer than ten, so there is no comparison to draw.
90 of the studies in Lymphoma with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03823534Phase 3St. Louis UniversityPost-Op Pain Control for Prophylactic Intramedullary Nailing. | 2026-12-31 |
| NCT04529772Phase 3Acerta Pharma BVA Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) | 2027-02-22 |
| NCT05006482Phase 3University of RochesterGeriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial | 2027-05-17 |
| NCT06356129Phase 3CelgeneStudy to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma | 2027-08-09 |
| NCT06084936Phase 3Hoffmann-La RocheA Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma | 2027-08-31 |
Among the 1,909 studies in Lymphoma with a site in United States, from their registry updates:
Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life. Such toxicities are largely due to tissue damage sustained by chemotherapy, and strategies designed to limit such cellular damage to normal tissues may reduce therapy-related morbidity and mortality. In addition to their in vitro and in vivo anti-cancer effects, naturally occurring soy isoflavones have anti-inflammatory and anti-oxidant properties, and have been shown to reduce side effects of therapy in adult oncology clinical trials. This study will examine the effect of genistein, the major isoflavone component in soybeans and the most extensively studied of the soy isoflavones, on short-term side effects of myelosuppressive chemotherapy in pediatric cancer patients. Subjects will be randomized to receive either: a) 30 mg genistein daily throughout chemotherapy Cycles 1 and 2 and placebo during chemotherapy Cycles 3 and 4; or b) placebo daily during chemotherapy Cycles 1 and 2 and 30 mg genistein daily during chemotherapy Cycles 3 and 4. Investigators hypothesize that subjects will have fewer short-term therapy-related side effects during cycles of chemotherapy given in conjunction with genistein supplementation than cycles given with placebo.
This is a multi-center, randomized, double blind, placebo-controlled crossover study to evaluate the effect of soy isoflavones on the short term untoward effects of myelosuppressive chemotherapy used to treat pediatric cancers. Newly diagnosed cancer patients aged 1-21 years will be registered to the study and informed consent will be obtained prior to any study-related procedures. Stratification will be based on length of chemotherapy cycles, between 14 day and 21 day cycles. Within strata registered subjects will be randomized 1:1 to one of two schedules:
Arm A: Subjects will receive genistein daily throughout chemotherapy cycles 1 and 2, and placebo during chemotherapy cycles 3 and 4
Arm B: Subjects will receive placebo daily throughout chemotherapy cycles 1 and 2, and genistein during chemotherapy cycles 3 and 4
Subjects will be assessed for safety and efficacy during each cycle with clinical labs, cytokine panels, and physical exams. Drug compliance will be monitored by use of a patient diary as well as monitoring of serum genistein levels. Adverse events will be monitored starting on Cycle 1 Day 1 through 30 days following the last day of protocol therapy (genistein/placebo).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Planned chemotherapeutic regimen for a patient must meet all of the following criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Drug: Genistein · Drug: Placebo
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Drug: Genistein · Drug: Placebo
Estrogen-like compound (isoflavone) derived from soybeans
Also known as: 5, 7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one, i-cool tablets containing 30 mg geniVida™
Pill that contains no medicine
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy
Time frame: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Days That Antimicrobial Treatment is Administered
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest
Time frame: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy
Time frame: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delays
| Milestone | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
| days | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein |
|---|---|---|
| Genistein cycles | 13.75 ± 1.26 | 12.67 ± 2.08 |
| Placebo cycles | 15.5 ± 1.73 | 13.5 ± 2.12 |
| mm/hr | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein |
|---|---|---|
| ESR, Genistein cycles | 14.67 ± 4.93 | 3.25 ± 1.5 |
| ESR, Placebo cycles | 20.00 ± 5.29 | 2.50 ± 0.58 |
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
| days | Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Arm B: Placebo Followed by Genistein - PLACEBO Cycles |
|---|---|---|---|---|
| Genistein Cycles | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Placebo Cycles | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
| Participants | Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Arm B: Placebo Followed by Genistein - PLACEBO Cycles |
|---|---|---|---|---|
| Genistein Cycles | 0 | 0 | 0 | 0 |
| Placebo Cycles | 0 | 0 | 0 | 0 |
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
| Events | Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Arm B: Placebo Followed by Genistein - PLACEBO Cycles |
|---|---|---|---|---|
| Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| days | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein |
|---|---|---|
| Genistein cycles | 0.75 ± 0.5 | 0.5 ± 0.58 |
| Placebo cycles | 0.5 ± 0.58 | 0.25 ± 0.5 |
| days | Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Arm B: Placebo Followed by Genistein - PLACEBO Cycles |
|---|---|---|---|---|
| Genistein Cycles | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Placebo Cycles | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| percentage of participants | Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Arm B: Placebo Followed by Genistein - PLACEBO Cycles |
|---|---|---|---|---|
| Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event | 0 | 0 | 0 | 0 |
| days | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein |
|---|---|---|
| Genistein cycles | 0 (0 to 0) | 0 (0 to 0) |
| Placebo cycles | 0 (0 to 0) | 5 (0 to 5) |
| cycles | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein |
|---|---|---|
| Genistein cycles | 2 | 0 |
| Placebo cycles | 0 | 0 |
| transfusions | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein |
|---|---|---|
| Genistein cycles | 0.75 ± 0.96 | 1.00 ± 1.15 |
| Placebo cycles | 1.25 ± 0.50 | 0.75 ± 0.96 |
| mg/dL | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein |
|---|---|---|
| CRP, Genistein cycles | 0.37 ± 0.29 | 0.13 ± 0.05 |
| CRP, Placebo cycles | 0.33 ± 0.26 | 0.15 ± 0.10 |
Collected over All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | 1/2 (50%) | 1/2 (50%) | 2/2 (100%) |
| Arm A: Genistein Followed by Placebo - PLACEBO Cycles | 0/2 (0%) | 1/2 (50%) | 0/2 (0%) |
| Arm B: Placebo Followed by Genistein - PLACEBO Cycles | 0/2 (0%) | 1/2 (50%) | 0/2 (0%) |
| Event | Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Arm B: Placebo Followed by Genistein - PLACEBO Cycles |
|---|---|---|---|---|
| febrile neutropeniaBlood and lymphatic system disorders | 1/2 | 1/2 | 1/2 | 1/2 |
| Event | Arm A: Genistein Followed by Placebo - GENISTEIN Cycles | Arm B: Placebo Followed by Genistein - GENISTEIN Cycles | Arm A: Genistein Followed by Placebo - PLACEBO Cycles | Arm B: Placebo Followed by Genistein - PLACEBO Cycles |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/2 | 2/2 | — | — |
| Neutrophil count decreasedInvestigations | 2/2 | 1/2 | — | — |
| Platelet count decreasedInvestigations | 2/2 | 1/2 | — | — |
| White blood cell count decreasedInvestigations | 2/2 | 1/2 | — | — |
| AnemiaBlood and lymphatic system disorders | 1/2 | 1/2 | — | — |
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/2 | 1/2 | — | — |
| Abdominal painGastrointestinal disorders | 1/2 | 0/2 | — | — |
| VomitingGastrointestinal disorders | 1/2 | 1/2 | — | — |
| DiarrheaGastrointestinal disorders | 1/2 | 0/2 | — | — |
| Anal mucositisGastrointestinal disorders | 1/2 | 0/2 | — | — |
| Age, Categorical(Participants) | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein | Total |
|---|---|---|---|
| <=18 years | 2 | 2 | 4 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein | Total |
|---|---|---|---|
| Mean | 14 (12 to 16) | 10 (8 to 12) | 12 (8 to 16) |
| Sex: Female, Male(Participants) | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 2 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm A: Genistein Followed by Placebo | Arm B: Placebo Followed by Genistein | Total |
|---|---|---|---|
| United States | 2 | 2 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Aug 2016, a primary completion of Sep 2021 and a completion of Sep 2021. It does not say whether these dates are actual or estimated.
Results were first posted in May 2024, 2 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Genistein